Teltoheart UDI: Difference between revisions
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<div style="background: linear-gradient(135deg, # | <div style="background: linear-gradient(135deg, #0a1628 0%, #0f2540 55%, #0054A6 100%); border-radius: 14px; padding: 36px 40px; margin-bottom: 24px; box-shadow: 0 4px 24px rgba(0,0,0,0.22);"> | ||
<div style="display:inline-block; background:rgba(255,255,255,0.1); border:1px solid rgba(255,255,255,0. | <div style="display:inline-block; background:rgba(255,255,255,0.1); border:1px solid rgba(255,255,255,0.18); border-radius:6px; padding:4px 12px; font-size:11px; font-weight:700; letter-spacing:2px; text-transform:uppercase; color:#9fc4e8; margin-bottom:14px;">Medical Device Identification</div> | ||
<div style="font-size: 30px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 10px;">Unique Device Identifier <span style="color:#63b3ed;">(UDI)</span></div> | <div style="font-size: 30px; font-weight: 700; color: #ffffff; letter-spacing: -0.5px; margin-bottom: 10px;">Unique Device Identifier <span style="color:#63b3ed;">(UDI)</span></div> | ||
<div style="color: # | <div style="color: #a8c2dc; font-size: 14px; line-height: 1.7; max-width:700px;">A unique numeric or alphanumeric code used to identify medical devices throughout the healthcare supply chain — from manufacturing through distribution to patient use. UDIs appear on device labels in both human-readable and machine-readable (barcode) formats.</div> | ||
</div> | </div> | ||
<!-- Description --> | <!-- Description --> | ||
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 12px; padding: 28px 32px; margin-bottom: | <div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 12px; padding: 28px 32px; margin-bottom: 20px; box-shadow:0 1px 4px rgba(0,0,0,0.05);"> | ||
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1.5px; color: # | <div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1.5px; color: #94a3b8; margin-bottom: 16px;">📄 Description</div> | ||
<div style="font-size: 14px; color: #2d3748; line-height: 1.8; margin-bottom: 20px;">The UDI system was established to unambiguously identify specific medical devices on the market and facilitate their traceability. It is a regulatory requirement across major health authorities including the EU (EUDAMED) and US (FDA). The UDI consists of two parts:</div> | <div style="font-size: 14px; color: #2d3748; line-height: 1.8; margin-bottom: 20px;">The UDI system was established to unambiguously identify specific medical devices on the market and facilitate their traceability. It is a regulatory requirement across major health authorities including the EU (EUDAMED) and US (FDA). The UDI consists of two parts:</div> | ||
<div style="display:flex; gap:16px; margin-bottom:20px;"> | <div style="display:flex; gap:16px; margin-bottom:20px;"> | ||
<div style="flex:1; background:linear-gradient(135deg,# | <div style="flex:1; background:linear-gradient(135deg,#eef6ff,#e3f0fc); border:1px solid #b6d7f5; border-radius:10px; padding:18px 20px;"> | ||
<div style="font-size:11px; font-weight:700; text-transform:uppercase; letter-spacing:1px; color:# | <div style="font-size:11px; font-weight:700; text-transform:uppercase; letter-spacing:1px; color:#0054A6; margin-bottom:8px;">🔒 Device Identifier (DI)</div> | ||
<div style="font-size:13px; color:#2d3748; line-height:1.7;">The <strong>mandatory, fixed</strong> portion of the UDI. Identifies the labeler and the specific version or model of a device. This value is the same for all units of the same product model.</div> | <div style="font-size:13px; color:#2d3748; line-height:1.7;">The <strong>mandatory, fixed</strong> portion of the UDI. Identifies the labeler and the specific version or model of a device. This value is the same for all units of the same product model.</div> | ||
</div> | </div> | ||
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<div style="background: linear-gradient(135deg, # | <div style="background: linear-gradient(135deg, #eef6ff, #f0f7ff); border: 1px solid #b6d7f5; border-left: 4px solid #0054A6; border-radius: 8px; padding: 14px 18px; font-size: 14px; color: #1a3a5c; line-height: 1.7;"> | ||
<strong>💡 GS1 Application Identifiers (AI)</strong><br/> | <strong>💡 GS1 Application Identifiers (AI)</strong><br/> | ||
The codes in parentheses are GS1 Application Identifiers: <br> | The codes in parentheses are GS1 Application Identifiers:<br/> | ||
<strong>(01)</strong> = GTIN (Global Trade Item Number), | <strong>(01)</strong> = GTIN (Global Trade Item Number), | ||
<strong>(10)</strong> = Batch/Lot Number, | <strong>(10)</strong> = Batch/Lot Number, | ||
<strong>(11)</strong> = Manufacturing Date, | <strong>(11)</strong> = Manufacturing Date, | ||
<strong>(8012)</strong> = Software Version. | <strong>(8012)</strong> = Software Version. | ||
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<!-- TeltoHeart UDI --> | <!-- TeltoHeart UDI --> | ||
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 12px; padding: 28px 32px; margin-bottom: | <div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 12px; padding: 28px 32px; margin-bottom: 20px; box-shadow:0 1px 4px rgba(0,0,0,0.05);"> | ||
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1.5px; color: # | <div style="display:flex; align-items:center; justify-content:space-between; margin-bottom:8px; flex-wrap:wrap; gap:8px;"> | ||
<div style="font-size:13px; color:#718096; margin-bottom:20px;"> | <div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1.5px; color: #94a3b8;">🏷️ TeltoHeart UDI Codes</div> | ||
<div style="font-size:11px; font-weight:700; text-transform:uppercase; letter-spacing:0.5px; color:#0054A6; background:#eef6ff; border:1px solid #b6d7f5; border-radius:20px; padding:3px 12px;">Hardware</div> | |||
</div> | |||
<div style="font-size:13px; color:#718096; margin-bottom:20px;">Includes batch number and manufacturing date as Production Identifiers.</div> | |||
< | <div style="display:flex; gap:14px; flex-wrap:wrap;"> | ||
< | <div style="flex:1; min-width:220px; background: linear-gradient(180deg, #f7fafc 0%, #edf2f7 100%); border: 1px solid #e2e8f0; border-radius: 10px; padding: 22px 18px; box-shadow:0 2px 6px rgba(0,0,0,0.04);"> | ||
<div style="display:block; width:fit-content; margin:0 auto 14px auto; background:#0054A6; border-radius:20px; padding:2px 14px; font-size:11px; font-weight:700; letter-spacing:1px; text-transform:uppercase; color:#fff;">Size S</div> | |||
<div style="display: | |||
<div style="font-family:'Courier New', monospace; font-size:13px; color:#4a5568; line-height:2; background:#edf2f7; border-radius:8px; padding:12px 14px;"> | <div style="font-family:'Courier New', monospace; font-size:13px; color:#4a5568; line-height:2; background:#edf2f7; border-radius:8px; padding:12px 14px;"> | ||
<span style="color:# | <span style="color:#0054A6; font-weight:700;">(01)</span>04779051850181<br/> | ||
<span style="color:#e53e3e; font-weight:700;">(10)</span>Batch number<br/> | <span style="color:#e53e3e; font-weight:700;">(10)</span>Batch number<br/> | ||
<span style="color:#d69e2e; font-weight:700;">(11)</span>Manufacturing date | <span style="color:#d69e2e; font-weight:700;">(11)</span>Manufacturing date | ||
</div> | </div> | ||
</ | </div> | ||
< | <div style="flex:1; min-width:220px; background: linear-gradient(180deg, #f7fafc 0%, #edf2f7 100%); border: 1px solid #e2e8f0; border-radius: 10px; padding: 22px 18px; box-shadow:0 2px 6px rgba(0,0,0,0.04);"> | ||
<div style="display: | <div style="display:block; width:fit-content; margin:0 auto 14px auto; background:#0054A6; border-radius:20px; padding:2px 14px; font-size:11px; font-weight:700; letter-spacing:1px; text-transform:uppercase; color:#fff;">Size M</div> | ||
<div style="font-family:'Courier New', monospace; font-size:13px; color:#4a5568; line-height:2; background:#edf2f7; border-radius:8px; padding:12px 14px;"> | <div style="font-family:'Courier New', monospace; font-size:13px; color:#4a5568; line-height:2; background:#edf2f7; border-radius:8px; padding:12px 14px;"> | ||
<span style="color:# | <span style="color:#0054A6; font-weight:700;">(01)</span>04779051850167<br/> | ||
<span style="color:#e53e3e; font-weight:700;">(10)</span>Batch number<br/> | <span style="color:#e53e3e; font-weight:700;">(10)</span>Batch number<br/> | ||
<span style="color:#d69e2e; font-weight:700;">(11)</span>Manufacturing date | <span style="color:#d69e2e; font-weight:700;">(11)</span>Manufacturing date | ||
</div> | </div> | ||
</ | </div> | ||
< | <div style="flex:1; min-width:220px; background: linear-gradient(180deg, #f7fafc 0%, #edf2f7 100%); border: 1px solid #e2e8f0; border-radius: 10px; padding: 22px 18px; box-shadow:0 2px 6px rgba(0,0,0,0.04);"> | ||
<div style="display: | <div style="display:block; width:fit-content; margin:0 auto 14px auto; background:#0054A6; border-radius:20px; padding:2px 14px; font-size:11px; font-weight:700; letter-spacing:1px; text-transform:uppercase; color:#fff;">Size L</div> | ||
<div style="font-family:'Courier New', monospace; font-size:13px; color:#4a5568; line-height:2; background:#edf2f7; border-radius:8px; padding:12px 14px;"> | <div style="font-family:'Courier New', monospace; font-size:13px; color:#4a5568; line-height:2; background:#edf2f7; border-radius:8px; padding:12px 14px;"> | ||
<span style="color:# | <span style="color:#0054A6; font-weight:700;">(01)</span>04779051850198<br/> | ||
<span style="color:#e53e3e; font-weight:700;">(10)</span>Batch number<br/> | <span style="color:#e53e3e; font-weight:700;">(10)</span>Batch number<br/> | ||
<span style="color:#d69e2e; font-weight:700;">(11)</span>Manufacturing date | <span style="color:#d69e2e; font-weight:700;">(11)</span>Manufacturing date | ||
</div> | </div> | ||
</ | </div> | ||
</ | </div> | ||
<!-- Legend --> | <!-- Legend --> | ||
<div style="margin-top: | <div style="margin-top:16px; padding:10px 14px; background:#f7fafc; border-radius:8px; font-size:12px; color:#718096; display:flex; gap:20px; flex-wrap:wrap;"> | ||
<span><span style="color:# | <span><span style="color:#0054A6; font-weight:700;">(01)</span> GTIN — Device Identifier</span> | ||
<span><span style="color:#e53e3e; font-weight:700;">(10)</span> Batch / Lot Number</span> | <span><span style="color:#e53e3e; font-weight:700;">(10)</span> Batch / Lot Number</span> | ||
<span><span style="color:#d69e2e; font-weight:700;">(11)</span> Manufacturing Date</span> | <span><span style="color:#d69e2e; font-weight:700;">(11)</span> Manufacturing Date</span> | ||
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</div> | </div> | ||
<!-- | <!-- MyHealth app UDI --> | ||
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 12px; padding: 28px 32px; margin-bottom: 24px; box-shadow:0 1px 4px rgba(0,0,0,0.05);"> | <div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 12px; padding: 28px 32px; margin-bottom: 24px; box-shadow:0 1px 4px rgba(0,0,0,0.05);"> | ||
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1.5px; color: # | <div style="display:flex; align-items:center; justify-content:space-between; margin-bottom:8px; flex-wrap:wrap; gap:8px;"> | ||
<div style="font-size:13px; color:#718096; margin-bottom:20px;"> | <div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1.5px; color: #94a3b8;">🏷️ MyHealth App UDI Code</div> | ||
<div style="font-size:11px; font-weight:700; text-transform:uppercase; letter-spacing:0.5px; color:#6b46c1; background:#f3ecfd; border:1px solid #d4bef5; border-radius:20px; padding:3px 12px;">Software</div> | |||
</div> | |||
<div style="font-size:13px; color:#718096; margin-bottom:20px;">Used in both TeltoHeart and TeltoCare software. Includes software version number as the Production Identifier.</div> | |||
<div style="max-width: | <div style="max-width:420px; margin:0 auto; background: linear-gradient(180deg, #f7fafc 0%, #edf2f7 100%); border: 1px solid #e2e8f0; border-radius: 10px; padding: 22px 18px; box-shadow:0 2px 6px rgba(0,0,0,0.04); text-align:center;"> | ||
<div style="display:inline-block; background:#6b46c1; border-radius:20px; padding:2px 14px; font-size:11px; font-weight:700; letter-spacing:1px; text-transform:uppercase; color:#fff; margin-bottom:14px;">MyHealth | <div style="display:inline-block; background:#6b46c1; border-radius:20px; padding:2px 14px; font-size:11px; font-weight:700; letter-spacing:1px; text-transform:uppercase; color:#fff; margin-bottom:14px;">MyHealth App</div> | ||
<div style="font-family:'Courier New', monospace; font-size: | <div style="font-family:'Courier New', monospace; font-size:14px; color:#4a5568; line-height:2; background:#edf2f7; border-radius:8px; padding:14px 16px; text-align:left;"> | ||
<span style="color:# | <span style="color:#0054A6; font-weight:700;">(01)</span>04779051850174<br/> | ||
<span style="color:#6b46c1; font-weight:700;">(8012)</span>1.0.0 | <span style="color:#6b46c1; font-weight:700;">(8012)</span>1.0.0 | ||
</div> | </div> | ||
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<div style="margin-top:14px; padding:10px 14px; background:#f7fafc; border-radius:8px; font-size:12px; color:#718096; display:flex; gap:20px; flex-wrap:wrap;"> | <div style="margin-top:14px; padding:10px 14px; background:#f7fafc; border-radius:8px; font-size:12px; color:#718096; display:flex; gap:20px; flex-wrap:wrap;"> | ||
<span><span style="color:# | <span><span style="color:#0054A6; font-weight:700;">(01)</span> GTIN — Device Identifier</span> | ||
<span><span style="color:#6b46c1; font-weight:700;">(8012)</span> Software Version Number</span> | <span><span style="color:#6b46c1; font-weight:700;">(8012)</span> Software Version Number</span> | ||
</div> | </div> | ||
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<!-- External Links --> | <!-- External Links --> | ||
<div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 12px; padding: 24px 32px; box-shadow:0 1px 4px rgba(0,0,0,0.05);"> | <div style="background: #ffffff; border: 1px solid #e2e8f0; border-radius: 12px; padding: 24px 32px; box-shadow:0 1px 4px rgba(0,0,0,0.05);"> | ||
<div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1.5px; color: # | <div style="font-size: 11px; font-weight: 700; text-transform: uppercase; letter-spacing: 1.5px; color: #94a3b8; margin-bottom: 14px;">🔗 External Links</div> | ||
<div style="display: flex; flex-direction: column; gap: 10px;"> | <div style="display: flex; flex-direction: column; gap: 10px;"> | ||
<div style="padding:11px 16px; border-radius:8px; font-size:13px; font-weight:600; color:# | <div style="padding:11px 16px; border-radius:8px; font-size:13px; font-weight:600; color:#0054A6; background:#eef6ff; border:1px solid #b6d7f5;">[https://health.ec.europa.eu/medical-devices-topics-interest/unique-device-identifier-udi_en 🌐 European Commission — UDI for Medical Devices →]</div> | ||
<div style="padding:11px 16px; border-radius:8px; font-size:13px; font-weight:600; color:# | <div style="padding:11px 16px; border-radius:8px; font-size:13px; font-weight:600; color:#0054A6; background:#eef6ff; border:1px solid #b6d7f5;">[https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics 🌐 FDA — UDI Basics →]</div> | ||
<div style="padding:11px 16px; border-radius:8px; font-size:13px; font-weight:600; color:# | <div style="padding:11px 16px; border-radius:8px; font-size:13px; font-weight:600; color:#0054A6; background:#eef6ff; border:1px solid #b6d7f5;">[https://www.gs1.org/industries/healthcare/udi 🔍 GS1 — UDI Standards →]</div> | ||
</div> | </div> | ||
</div> | </div> | ||
Latest revision as of 12:38, 7 July 2026
Main Page > TeltoHeart > Teltoheart UDI
Medical Device Identification
Unique Device Identifier (UDI)
A unique numeric or alphanumeric code used to identify medical devices throughout the healthcare supply chain — from manufacturing through distribution to patient use. UDIs appear on device labels in both human-readable and machine-readable (barcode) formats.
📄 Description
The UDI system was established to unambiguously identify specific medical devices on the market and facilitate their traceability. It is a regulatory requirement across major health authorities including the EU (EUDAMED) and US (FDA). The UDI consists of two parts:
🔒 Device Identifier (DI)
The mandatory, fixed portion of the UDI. Identifies the labeler and the specific version or model of a device. This value is the same for all units of the same product model.
🔄 Production Identifier (PI)
The variable portion of the UDI. Identifies production-specific characteristics such as batch/lot number, manufacturing date, expiration date, or serial number.
💡 GS1 Application Identifiers (AI)
The codes in parentheses are GS1 Application Identifiers:
(01) = GTIN (Global Trade Item Number),
(10) = Batch/Lot Number,
(11) = Manufacturing Date,
(8012) = Software Version.
🏷️ TeltoHeart UDI Codes
Hardware
Includes batch number and manufacturing date as Production Identifiers.
Size S
(01)04779051850181
(10)Batch number
(11)Manufacturing date
Size M
(01)04779051850167
(10)Batch number
(11)Manufacturing date
Size L
(01)04779051850198
(10)Batch number
(11)Manufacturing date
(01) GTIN — Device Identifier (10) Batch / Lot Number (11) Manufacturing Date
🏷️ MyHealth App UDI Code
Software
Used in both TeltoHeart and TeltoCare software. Includes software version number as the Production Identifier.
MyHealth App
(01)04779051850174
(8012)1.0.0
(01) GTIN — Device Identifier (8012) Software Version Number