Skip to content

Ballard™ 197-4J

by SunMed GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889483623237 UDI-DIDate18 Nov 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  • Withdrawn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 23 Oct 2026.

Specification

GUDID

Trade Name
Ballard™
Generic Name
Suction system catheter, general-purpose
Model / Ref / Catalog
197-4J
Primary DI / UDI-DI
10889483623237
FDA Product Code
BSY
GMDN Term
Suction system catheter, general-purpose
Device Class
Class I
Regulation Number
868.6810
GUDID distribution status
In Commercial Distribution

Other devices from SunMed

See all devices from SunMed →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number

Other properties (8)

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