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Gabriel Feeding Tube with Balloon 8 Fr

by Syncro Medical Innovations, Inc. 2 variants

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 Number00860000931304 UDI-DI Date24 Jan 2019ListedStatusListed 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  • Withdrawn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 Feeding Tube with Balloon
Generic Name
Nasogastric feeding tube
Model / Ref / Catalog
8 Fr, GFTB 408
Primary DI / UDI-DI
00860000931304
510(k) Number
FDA Product Code
KNT
GMDN Term
Nasogastric feeding tube
Device Class
Class II
Regulation Number
876.5980
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Catheter Gauge — 8 French

Related devices

Category: Nasogastric feeding tube

Cleared under the same submission (K160787)

Other devices from Syncro Medical Innovations, Inc.

See all devices from Syncro Medical Innovations, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No