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Teltoheart UDI: Difference between revisions

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<div style="display:flex; align-items:center; justify-content:space-between; margin-bottom:8px; flex-wrap:wrap; gap:8px;">
<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: 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 Device</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>
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<div style="font-size:13px; color:#718096; margin-bottom:20px;">Includes batch number and manufacturing date as Production Identifiers.</div>
<div style="font-size:13px; color:#718096; margin-bottom:20px;">Includes batch number and manufacturing date as Production Identifiers.</div>
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<div style="display:flex; align-items:center; justify-content:space-between; margin-bottom:8px; flex-wrap:wrap; gap:8px;">
<div style="display:flex; align-items:center; justify-content:space-between; margin-bottom:8px; flex-wrap:wrap; gap:8px;">
<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: 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 Device</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>
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<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="font-size:13px; color:#718096; margin-bottom:20px;">Used in both TeltoHeart and TeltoCare software. Includes software version number as the Production Identifier.</div>


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<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 App Software</div>
<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>
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<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:#0054A6; font-weight:700;">(01)</span>04779051850174<br/>
<span style="color:#0054A6; font-weight:700;">(01)</span>04779051850174<br/>

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