UDI device identifier

CVS Health Digital Wide-Tip & Advanced Early Result Pregnancy Tests

UDI device identifier 00050428079249 · WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Key facts

Primary DI 00050428079249
Brand name CVS Health
Version or model Digital Wide-Tip & Advanced Early Result Pregnancy Tests
Company WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
DUNS number 062312574
Product code LCX
GMDN term Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Premarket submission K042280
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Oct 28, 2024
Version date Nov 5, 2024
Description A convenience test consisting of 1 Digital Wide-Tip Test and 1 Advanced Early Result Test

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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