← Back to catalogue

t:connect Mobile Application, Mobile Bolus Enabled (Android)

FDA UDI

Class II (US FDA UDI)

by Tandem Diabetes Care, Inc.

Identity

Trade Name
t:connect Mobile Application, Mobile Bolus Enabled (Android) FDA UDI
Generic Name
Ambulatory insulin infusion pump software, data-display FDA UDI
Device Name
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (Android) FDA UDI
Model / Reference
1007112 FDA UDI
Description
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (Android) FDA UDI

Identifiers

Primary DI / UDI-DI
90850018992445 FDA UDI
FDA Product Code
PJT FDA UDI
QFG FDA UDI
GMDN Term
Ambulatory insulin infusion pump software, data-display FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1350 FDA UDI
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

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ambulatory insulin infusion pump software, data-displayAmbulatory insulin infusion pump remote control

t:connect Mobile Application, Mobile Bolus Enabled (Android) by Tandem Diabetes Care, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Ambulatory insulin infusion pump remote control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Tandem Diabetes Care, Inc.

Sources (1)

  • FDA UDI cd672e31-31da-46e3-9709-b70f18653842 34 fields · synced Jun 8, 2026