AirLife - HMEF 1000/S and Flexible Tube, Disposable - Carefusion Finland 320 Oy

Duns Number:367919120

Device Description: HMEF 1000/S and Flexible Tube, Disposable

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More Product Details

Catalog Number

557071600

Brand Name

AirLife

Version/Model Number

557071600

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

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Device Record Status

Public Device Record Key

c7e863af-1493-4815-bd78-4a93da02dc1b

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

70885403255771

Quantity per Package

30

Contains DI Package

10885403255779

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack

"CAREFUSION FINLAND 320 OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 363