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Disposable Balloon Catheter B5-2C

by Olympus Medical Systems Corporation GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170047398 UDI-DIDate21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Disposable Balloon Catheter
Generic Name
Gastrointestinal/tracheobronchial balloon catheter
Model / Reference
B5-2C
Primary DI / UDI-DI
04953170047398
FDA Product Code
EOQ
GMDN Term
Gastrointestinal/tracheobronchial balloon catheter
Device Class
Class II
Regulation Number
874.4680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gastrointestinal/tracheobronchial balloon catheter

Cleared under the same submission (K962901)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No