UDI device identifier

Family Wellness 0939504

UDI device identifier 00032251057663 · FOURSTAR GROUP INC.

Key facts

Primary DI 00032251057663
Brand name Family Wellness
Version or model 0939504
Company FOURSTAR GROUP INC.
DUNS number 656091279
Product code LCX
GMDN term Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Premarket submission K150022
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date May 9, 2018
Version date Oct 14, 2024
Description Early Result Pregnancy Test 1CT

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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