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ThermoTek WRAP, DVT, CA, SET, PUSH, SPU, QTY 10, CTN 0P9BNDVTCA4-CTN

by Thermotek, Inc.

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 Number00850033615494 UDI-DI Date21 Feb 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  • Withdrawn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
ThermoTek WRAP,DVT,CA,SET,PUSH,SPU, QTY 10, CTN
Generic Name
Single-chamber venous compression system garment, single-use
Model / Ref / Catalog
0P9BNDVTCA4-CTN
Primary DI / UDI-DI
00850033615494
510(k) Number
FDA Product Code
JOW
GMDN Term
Single-chamber venous compression system garment, single-use
Device Class
Class II
Regulation Number
870.5800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K061866)

Show all (12)

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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