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Verifine RBC-2119A

by Promisemed Medical Devices 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 Number00850062218444 UDI-DI Date19 Jan 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  • Withdrawn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
Verifine
Generic Name
Luer-ended blood collection tube spike
Model / Reference
RBC-2119A
Primary DI / UDI-DI
00850062218444
510(k) Number
FDA Product Code
FMI
GMDN Term
Luer-ended blood collection tube spike
Device Class
Class II
Regulation Number
880.5570
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243806)

Show all (12)

Other devices from Promisemed Medical Devices Inc.

See all devices from Promisemed Medical Devices Inc. →

Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No