Tandem Mobi Autosoft XC Kit

FDA UDI

Class II (US FDA UDI)

by Tandem Diabetes Care, Inc.

Identity

Trade Name: Tandem Mobi Autosoft XC Kit FDA UDI
Generic Name: Ambulatory insulin infusion pump reservoir FDA UDI
Device Name: Autosoft XC 23"/6mm 10 pack FDA UDI
Model / Reference: 1014120 FDA UDI
Description: Autosoft XC 23"/6mm 10 pack FDA UDI

Identifiers

Primary DI / UDI-DI: 00389152412078 FDA UDI
FDA Product Code: QFG FDA UDI
FPA FDA UDI
GMDN Term: Ambulatory insulin infusion pump reservoir FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5730 FDA UDI
880.5440 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

Yes

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

Yes

FDA UDI

Category: Electric infusion pump administration set, single-use Ambulatory insulin infusion pump reservoir

Tandem Mobi Autosoft XC Kit by Tandem Diabetes Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ambulatory insulin infusion pump reservoir.

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DANA Diabecare — SOOIL DEVELOPMENT CO., LTD · Class II
iLet Insulin Infusion Kit - Inset (32”, 6mm) 15-Pack (Pharmacy Kit) — Beta Bionics, Inc. · Class II
iLet Starter Kit - Contact Detach — Beta Bionics, Inc. · Class II
CeQur Simplicity — Cequr SA · Class II
iLet Insulin Infusion Kit – Contact Detach™ (23"", 6mm) - 20-Pack — Beta Bionics, Inc. · Class II

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 205eca33-451c-496f-8d2d-45c8cf823fdc 33 fields · synced Jun 8, 2026