UDI device identifier

H.E.B Early Ovulation Kit Test

UDI device identifier 00041220524549 · H. E. BUTT GROCERY COMPANY

Key facts

Primary DI 00041220524549
Brand name H.E.B
Version or model Early Ovulation Kit Test
Company H. E. BUTT GROCERY COMPANY
DUNS number 007924756
Product code CEP
GMDN term Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Premarket submission K042280
Device class 1 | 2
Single use Yes
Packaged sterile No
Implantable No
Publish date Jun 13, 2021
Version date Feb 6, 2024
Description A convenience kit consisting of 10 Ovulation Test devices and 1 One-Step Pregnancy 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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