t:flex Cartridge, t:lock, 10 Pack

FDA UDI

Class II (US FDA UDI)

by Tandem Diabetes Care, Inc.

Identity

Trade Name: t:flex Cartridge, t:lock, 10 Pack FDA UDI
Generic Name: Ambulatory insulin infusion pump reservoir FDA UDI
Device Name: t:flex Insulin Pump Cartridges, t:lock, 10 pack FDA UDI
Model / Reference: 1001390 FDA UDI
Description: t:flex Insulin Pump Cartridges, t:lock, 10 pack FDA UDI

Identifiers

Primary DI / UDI-DI: 00853052007493 FDA UDI
FDA Product Code: LZG FDA UDI
GMDN Term: Ambulatory insulin infusion pump reservoir FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Total Volume — 4.8 Milliliter FDA UDI

Category: Ambulatory insulin infusion pump reservoir

t:flex Cartridge, t:lock, 10 Pack by Tandem Diabetes Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Tandem Diabetes Care, Inc.

Sources (1)

FDA UDI b17c2df0-cfd4-480e-b1a0-93705693d657 36 fields · synced Jun 8, 2026