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Infant Flow 675-CFG-001

by Carefusion

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10846446061895 UDI-DI Date1 May 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Infant Flow
Generic Name
Neonatal intensive-care ventilator
Model / Ref / Catalog
675-CFG-001
Primary DI / UDI-DI
10846446061895
510(k) Number
FDA Product Code
BZD
GMDN Term
Neonatal intensive-care ventilator
Device Class
Class II
Regulation Number
868.5905
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K031745)

Show all (12)

Other devices from Carefusion

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Properties

  • Prescription Use
  • Serial Number

Other properties (12)

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