FDA.report

Infant Flow SiPAP

Primary DI
20846446004271
Brand
Infant Flow SiPAP
Company
Carefusion Corporation
Model
11513-101
Catalog number
11513-101
Device description
INFANT FLOW, NASAL PRONGS, SMALL
Published
2015-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications

CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20846446004271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2084644600427120846446004271

GMDN Terms

TermDefinition
Neonatal intensive-care ventilatorA 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.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-231-2466support.smcvent.us@carefusion.
1-800-231-2466support.smcvent.us@carefusion.com

Regulatory Flags

DUNS number
830432451
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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