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RiskWise Health Kits RSTK-IND

by Riskwise Supplies LLC

Listed FDA GUDID listing, not in commercial distribution

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 Number00086001469732 UDI-DI Date18 May 2026ListedStatusListed GUDID: not 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  • Withdrawn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
RiskWise Health Kits
Generic Name
Surgical/medical respirator, non-antimicrobial, single-use
Model / Reference
RSTK-IND
Primary DI / UDI-DI
00086001469732
FDA Product Code
MSH
GMDN Term
Surgical/medical respirator, non-antimicrobial, single-use
Device Class
Class II
Regulation Number
878.4040
GUDID distribution status
Not in Commercial Distribution

Other devices from Riskwise Supplies LLC

Properties

  • Single Use
  • Over-the-Counter
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No