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K-Systems K23054

by CooperSurgical, Inc.

K-Systems K23054 is an assisted reproduction heater/incubator (FDA Class II; FDA product code PUB, Accessory, Assisted Reproduction, Exempt) made by CooperSurgical, Inc., listed in FDA GUDID since 13 May 2020 (UDI-DI 00888937025071), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00888937025071 UDI-DI Date13 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
K-Systems
Generic name
Assisted reproduction heater/incubator
Model / reference
K23054
Primary DI / UDI-DI
00888937025071
FDA product code
PUB
GMDN term
Assisted reproduction heater/incubator
Device class
Class II
Regulation number
884.6120
GUDID distribution status
In Commercial Distribution

Related devices

Category: Assisted reproduction heater/incubator

Similar devices in this category

Other devices filed under Assisted reproduction heater/incubator.

Other devices from CooperSurgical, Inc.

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)