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Kozee M21301

by Sourcemark, LLC.

Kozee M21301 is a Class II device made by Sourcemark, LLC., listed in FDA GUDID since 27 Jan 2020 (UDI-DI 08973920006693), 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 Number08973920006693 UDI-DI Date27 Jan 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  • Withdrawn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
Kozee
Generic name
Circulating-air whole-body heating system control unit
Model / reference
M21301
Description
Small Warming Suit
Primary DI / UDI-DI
08973920006693
FDA product code
DWJ
GMDN term
Circulating-air whole-body heating system control unit
Device class
Class II
Regulation number
870.5900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Circulating-air whole-body heating system control unit

Other devices from Sourcemark, LLC.

See all devices from Sourcemark, LLC. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)