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Tandem Mobi Starter Kit

FDA UDI

Class II (US FDA UDI)

by Tandem Diabetes Care, Inc.

Identity

Trade Name
Tandem Mobi Starter Kit FDA UDI
Generic Name
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm FDA UDI
Device Name
with Control-IQ 7.X FDA UDI
Model / Reference
1014081 FDA UDI
Description
with Control-IQ 7.X FDA UDI

Identifiers

Primary DI / UDI-DI
00389152408170 FDA UDI
510(k) Number
K223213 FDA UDI
FDA Product Code
QFG FDA UDI
QJI 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
862.1356 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

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

Tandem Mobi Starter Kit 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.

Cleared under the same submission

K223213 also covers:

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 c156d015-3691-443a-8a56-4bf34ae79b29 34 fields · synced Jun 8, 2026