FDA.reportPublic FDA data

AirLife

Primary DI
10885403070952
Brand
AirLife
Company
Carefusion Corporation
Model
AL2702
Catalog number
AL2702
Device description
Airlife™ Prefilled Humidifier. Sterile Water for Inhalation, USP, 750 ml With Humidifier Adapter
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403070950PackageGS112Not in Commercial Distribution
10885403070952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540307095050885403070950
1088540307095210885403070952

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous/irrigation solution storage container, single-useAn empty glass or plastic receptacle intended for the safe storage and easy handling of solutions (e.g., sterile distilled water or saline) that are used during intravenous (IV) and/or irrigation procedures; however, it is neither intended to be connected to an IV administration set nor to irrigation equipment. It is produced in a variety of sizes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid excessive heat
Special Storage Condition, Specify00Protect from freezing
Special Storage Condition, Specify00Room Temperature

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403006432AirLife0020060020062016-09-01
10885403011870AirLife9066-HS79066-HS72016-09-01
10885403026799AirLife10808-H1210808-H122016-09-01
10885403026850AirLife1212-H111212-H112016-09-01
10885403026881AirLife1704-H071704-H072016-09-01
10885403026959AirLife5753-H105753-H102016-09-01
10885403027024AirLife6463-H086463-H082016-09-01
10885403027055AirLife6814-H126814-H122016-09-01
10885403027116AirLife7102-HS77102-HS72016-09-01
10885403027130AirLife7104-HS77104-HS72016-09-01
10885403027154AirLife7142-HS77142-HS72016-09-01
10885403027185AirLife7149-HS77149-HS72016-09-01
10885403027260AirLife7418-HS37418-HS32016-09-01
10885403027314AirLife9037-HS79037-HS72016-09-01
10885403027390AirLife9061-HS79061-HS72016-09-01
10885403027420AirLife9064-HS79064-HS72016-09-01
10885403027444AirLife9065-HS79065-HS72016-09-01
10885403027451AirLife9073-HS79073-HS72016-09-01
10885403027581AirLifeRC6Y023034RC6Y0230342016-09-01
10885403027598AirLifeRT409-852RT409-8522016-09-01

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