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Wellell 9P-089000

by Wellell Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04719893351026 UDI-DI Date17 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Wellell
Generic Name
Sequential venous compression system inflator
Model / Reference
9P-089000
Primary DI / UDI-DI
04719893351026
FDA Product Code
JOW
GMDN Term
Sequential venous compression system inflator
Device Class
Class II
Regulation Number
870.5800
GUDID distribution status
In Commercial Distribution

Other devices from Wellell Inc.

See all devices from Wellell Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No
  • Manufacturing Date: No