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SourceMark M21028

by Sourcemark, LLC.

SourceMark M21028 is a Class II device made by Sourcemark, LLC., listed in FDA GUDID since 8 Jul 2020 (UDI-DI 00813799004384), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813799004384 UDI-DI Date8 Jul 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  • Withdrawn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
SourceMark
Generic name
Circulating-air whole-body heating system control unit
Model / reference
M21028
Primary DI / UDI-DI
00813799004384
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

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)