Teltoheart UDI
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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