Teltoheart UDI: Difference between revisions
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<div style="font-size:13px; color:#718096; margin-bottom:20px;">Software device — includes software version number as the Production Identifier.</div> | <div style="font-size:13px; color:#718096; margin-bottom:20px;">Software device — includes software version number as the Production Identifier.</div> | ||
<div style="max-width:400px; 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="max-width:400px; 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 Software</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; text-align:left;"> | ||
<span style="color:#3182ce; font-weight:700;">(01)</span>04779051850174<br/> | <span style="color:#3182ce; 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> | ||
</div> | </div> | ||
Revision as of 10:26, 29 June 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 device — includes batch number and manufacturing date as Production Identifiers.
|
Size S
(01)04779051850181 |
Size M
(01)04779051850167 |
Size L
(01)04779051850198 |
(01) GTIN — Device Identifier (10) Batch / Lot Number (11) Manufacturing Date
🏷️ MyHealth app UDI Code (used in TeltoHeart and TeltoCare software)
Software device — includes software version number as the Production Identifier.
MyHealth app Software
(01)04779051850174
(8012)1.0.0
(01) GTIN — Device Identifier (8012) Software Version Number