AccessGUDID - DEVICE: Infant Flow SiPAP (20846446004417)

GUDID

Device Identifier (DI) Information

Brand Name: Infant Flow SiPAP
Version or Model: 777040M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 777040M
Company Name: Carefusion Corporation

Primary DI Number: 20846446004417
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 830432451 *Terms of Use

Device Description: INFANT FLOW LP, HEADGEAR, M

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14361	Neonatal intensive-care ventilator	A mains electricity (AC-powered) automatic cycling device intended for short-term and long-term ventilatory support for a neonatal/paediatric patient, especially those preterm and critically ill with respiratory failure in a critical care setting. It is typically a time-cycled, pressure-control device that includes a small bore flexible tube breathing system. It may be capable of high frequency oscillatory ventilation in addition to conventional ventilation, and includes positive end-expiratory pressure (PEEP) and continuous positive airway pressure (CPAP) controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBK	Ventilator, Continuous, Facility Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 697744c8-9842-4b2e-b8a4-7f16069318e1
Public Version Date: June 06, 2024
Public Version Number: 3
DI Record Publish Date: September 16, 2015