UDI device identifier

Tandem Mobi Starter Kit 1014081

UDI device identifier 00389152408170 · Tandem Diabetes Care, Inc.

Key facts

Primary DI 00389152408170
Brand name Tandem Mobi Starter Kit
Version or model 1014081
Company Tandem Diabetes Care, Inc.
DUNS number 827900809
Product code QFG
GMDN term Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Premarket submission K223213
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Jun 21, 2024
Version date Jul 1, 2024
Description with Control-IQ 7.X

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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