UDI device identifier

H.E.B One Step Digital Pregnancy Test

UDI device identifier 00041220524440 · H. E. BUTT GROCERY COMPANY

Key facts

Primary DI 00041220524440
Brand name H.E.B
Version or model One Step Digital Pregnancy Test
Company H. E. BUTT GROCERY COMPANY
DUNS number 007924756
Product code LCX
GMDN term Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Premarket submission K060128
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Feb 6, 2019
Version date Jul 6, 2023
Description CB8 HEB DPS Digital Early 2ct

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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