Infant Flow SiPAP

Basic Information

• Brand Name: Infant Flow SiPAP
• Primary DI: 10846446063264
• Version / Model: 27415-001
• Company Name: Carefusion Corporation
• Labeler DUNS: 830432451
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-29
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1ff94386-4743-499a-b8a2-6227851f7632

Device Description

SIPAP, IF, PLUS, AUX, MDISS, ENGLISH

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10846446063264	GS1