FDA.reportPublic FDA data

AirLife

Primary DI
50885403026612
Brand
AirLife
Company
Carefusion Corporation
Model
2D0735X
Catalog number
2D0735X
Device description
Airlife™ Sterile Water for Inhalation, USP 1000 ml
Published
2016-09-01
Public version status
Update
Distribution status
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
50885403026612PackageGS114In Commercial Distribution
10885403026614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540302661250885403026612
1088540302661410885403026614

GMDN Terms#

Term, Definition table
TermDefinition
Sterile solution storage bottle, single-useAn empty glass or plastic container, typically with a relatively narrow neck, intended for the safe storage and easy handling of sterile solutions (e.g., sterile distilled water or saline) that are used during intravenous and/or irrigation procedures. It is produced in a variety of sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

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
false
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10197344016938HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016945HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016969HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016976HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016983HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016990HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
00841737100775Vapotherm Inc.VAPOTHERM, INC.BTT2026-06-23
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09420012480729F&P OptiflowFISHER & PAYKEL HEALTHCARE LIMITEDBTT2025-11-07
00810083350561SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
00810083350585SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
10889483570906AirLife™AIRLIFEBTT2025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief ValveAIRLIFEBTT2025-02-20
10889483571477Airlife™ Sterile Water for Inhalation, USP, 500 mlAIRLIFEBTT2025-02-20
10197344009749HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-10-31
10197344009756HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-09-24
07640140860749Monsoon III Laserjet 70Acutronic Medical Systems AGBTT2023-01-20
00810071637285CuraplexBOUND TREE MEDICAL, LLCBTT2022-12-30
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09420012416179Fisher and Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012428493F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012429117F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012429155F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012429711F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02