UDI device identifier

Sunmark Pregnancy Test One Step FPPL

UDI device identifier 00010939163332 · MCKESSON CORPORATION

Key facts

Primary DI 00010939163332
Brand name Sunmark Pregnancy Test One Step
Version or model FPPL
Company MCKESSON CORPORATION
DUNS number 177667227
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 Jun 30, 2016
Version date Jul 6, 2023
Description FPPL Sunmark DPS +/-

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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