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TruDVT TRU-X100

by Trumedx LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810175660103 UDI-DI Date11 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TruDVT
Generic Name
Intermittent venous compression system
Model / Reference
TRU-X100
Primary DI / UDI-DI
00810175660103
510(k) Number
FDA Product Code
JOW
GMDN Term
Intermittent venous compression system
Device Class
Class II
Regulation Number
870.5800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K202839)

Other devices from Trumedx LLC

See all devices from Trumedx LLC →

Properties

  • Single Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No