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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 Number04953170454226 UDI-DIDate16 Jun 2025ListedStatusListed 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  • Withdrawn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 22 Oct 2026.

Specification

GUDID

Trade Name
Disposable Balloon Catheter
Generic Name
Gastrointestinal/tracheobronchial balloon catheter
Model / Ref / Catalog
B5-2C, N6214640
Primary DI / UDI-DI
04953170454226
510(k) Number
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

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