UDI device identifier

Ahold - CareOne UPP 5mm pen needles AN 3850AH

UDI device identifier 00041520035363 · Ahold U.S.A., Inc.

Key facts

Primary DI 00041520035363
Brand name Ahold - CareOne UPP 5mm pen needles
Version or model AN 3850AH
Catalog number AN 3850AH
Company Ahold U.S.A., Inc.
DUNS number 170199058
Product code FMI
GMDN term Autoinjector needle
Premarket submission K152339
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Sep 19, 2016
Version date Jul 6, 2018
Description For use with injectors for the subcutaneous injection of approved drugs, including insulin

At a glance

  • 1–9 MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No 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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