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UltraFlow™ 603775

by Rochester Electro-Medical, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10816843021440 UDI-DIDate24 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
UltraFlow™
Generic Name
Patient monitoring system module, electrocardiographic/respiratory
Model / Reference
603775
Primary DI / UDI-DI
10816843021440
FDA Product Code
BZQ
GMDN Term
Patient monitoring system module, electrocardiographic/respiratory
Device Class
Class II
Regulation Number
868.2375
GUDID distribution status
Not in Commercial Distribution

Other devices from Rochester Electro-Medical, Inc.

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (10)

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