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Infant Flow SiPAP 777022

by Carefusion GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number50846446004623 UDI-DIDate16 Sep 2015ListedStatusListed 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  • Withdrawn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
Infant Flow SiPAP
Generic Name
Neonatal intensive-care ventilator
Model / Ref / Catalog
777022
Primary DI / UDI-DI
50846446004623
FDA Product Code
CBK
GMDN Term
Neonatal intensive-care ventilator
Device Class
Class II
Regulation Number
868.5895
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Carefusion

See all devices from Carefusion →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

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