AirLife - Airlife™ Sterile Water for Inhalation, USP - Carefusion Corporation

Duns Number:830432451

Device Description: Airlife™ Sterile Water for Inhalation, USP 1000 ml

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More Product Details

Catalog Number

2D0735X

Brand Name

AirLife

Version/Model Number

2D0735X

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BTT

Product Code Name

HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Device Record Status

Public Device Record Key

762bbafd-c7cc-4aa0-9177-1c5168778f31

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

50885403026612

Quantity per Package

14

Contains DI Package

10885403026614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"CAREFUSION CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 876
3 A medical device with high risk that requires premarket approval 29