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Gabriel 3-way EnFit Valve GEV-0001

by Syncro Medical Innovations, 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 Number00860000931366 UDI-DI Date7 Feb 2021ListedStatusListed 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  • Withdrawn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
Gabriel 3-way EnFit Valve
Generic Name
ENFit/non-ISO80369-standardized small-bore multichannel connector
Model / Ref / Catalog
GEV-0001
Primary DI / UDI-DI
00860000931366
510(k) Number
FDA Product Code
PIF
GMDN Term
ENFit/non-ISO80369-standardized small-bore multichannel connector
Device Class
Class II
Regulation Number
876.5980
GUDID distribution status
In Commercial Distribution

Related devices

Category: ENFit/non-ISO80369-standardized small-bore multichannel connector

Other devices from Syncro Medical Innovations, Inc.

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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