UDI device identifier

Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’ 1001216

UDI device identifier 00020221012163 · Exel International

Key facts

Primary DI 00020221012163
Brand name Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’
Version or model 1001216
Catalog number 1001216
Company Exel International
DUNS number 180572216
Product code FMF
GMDN term General-purpose syringe/needle
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Apr 17, 2023
Version date Jun 8, 2026
Description Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’ 100/BX, 800/CS

At a glance

  • None MAUDE reports citing this UDI
  • No Linked premarket submission
  • Yes EUDAMED counterpart found
  • 1,000+ 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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