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t:slim X2 Insulin Pump with Control-IQ Technology

FDA UDI

Class II (US FDA UDI)

by Tandem Diabetes Care, Inc.

Identity

Trade Name
t:slim X2 Insulin Pump with Control-IQ Technology FDA UDI
Generic Name
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm FDA UDI
Model / Reference
1012868 FDA UDI

Identifiers

Primary DI / UDI-DI
00389152286815 FDA UDI
FDA Product Code
QFG FDA UDI
GMDN Term
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

t:slim X2 Insulin Pump with Control-IQ Technology by Tandem Diabetes Care, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tandem Diabetes Care, Inc.

Sources (1)

  • FDA UDI 59547393-6f21-43f5-81d9-48ef955df727 32 fields · synced Jun 8, 2026