Replacement Cabel for ANAPOD - Replacement Cabel for ANAPOD - WESTMED, INC.

Duns Number:092673953

Device Description: Replacement Cabel for ANAPOD

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Replacement Cabel for ANAPOD

Version/Model Number

A4072

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 13, 2022

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"

Yes

For Single-Use

-

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

K870173

Product Code Details

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Device Record Status

Public Device Record Key

a2db4699-04e9-40ae-b31e-d532e5534486

Public Version Date

September 14, 2022

Public Version Number

2

DI Record Publish Date

September 25, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WESTMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 746
2 A medical device with a moderate to high risk that requires special controls. 320