AccessGUDID - DEVICE: Infant Flow SiPAP (70846446004733)

GUDID

Device Identifier (DI) Information

Brand Name: Infant Flow SiPAP
Version or Model: 777084-110
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 777084-110
Company Name: Carefusion Corporation

Primary DI Number: 70846446004733
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, BONNETS, 7, ORANGE

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: 495f3f8a-c253-4950-974a-8a0e612f9743
Public Version Date: June 06, 2024
Public Version Number: 3
DI Record Publish Date: September 30, 2015