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 Software

(01)04779051850174
(8012)1.0.0

(01) GTIN — Device Identifier (8012) Software Version Number

🔗 External Links

🌐 European Commission — UDI for Medical Devices →

🌐 FDA — UDI Basics →

🔍 GS1 — UDI Standards →