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SwiftSure SwishKit SK-001A

by Swiftsure Innovations 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 Number00628942257803 UDI-DI Date14 Apr 2023ListedStatusListed 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  • Withdrawn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
SwiftSure SwishKit
Generic Name
Suction/irrigation tubing, single-use
Model / Reference
SK-001A
Primary DI / UDI-DI
00628942257803
FDA Product Code
JOL
GMDN Term
Suction/irrigation tubing, single-use
Device Class
Class II
Regulation Number
880.6740
GUDID distribution status
In Commercial Distribution

Related devices

Category: Suction/irrigation tubing, single-use

Properties

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

Other properties (9)

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