FDA.reportPublic FDA data

AirLIfe

Primary DI
10885403220753
Brand
AirLIfe
Company
Carefusion Corporation
Model
2K7106
Catalog number
2K7106
Device description
"Pediatric Manual Resuscitator; 40""(1.0m) Oxygen Resevoir Tubing, Pediatric Mask, Pressure Limiting Valve with lock, Pressure Manometer, PEEP Valve, 10' O2 Tubing "
Published
2016-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEVCardiopulmonary Resuscitation Aid Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEVCardiopulmonary Resuscitation Aid KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403220751PackageGS112Not in Commercial Distribution
10885403220753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540322075150885403220751
1088540322075310885403220753

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume550Milliliter
Weight275Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Fahrenheit123 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.323.9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags#

DUNS number
830432451
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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10885403006555AirLife0024340024342016-09-01
10885403006562AirLife0024350024352016-09-01
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10885403006593AirLife0024440024442016-09-01
10885403010958AirLife0024460024462016-09-01
10885403010996AirLife0025010025012016-09-01
10885403011726AirLife0016180016182016-09-01
10885403026980AirLife6200-5046200-5042016-09-01
10885403027079AirLife6934-5046934-5042016-09-01
10885403039072AirLife0021730021732016-09-01

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