Heated circuit - 60` 28V Adult Htd Limb, St Water, 40 CM Pop Off - WESTMED, INC.

Duns Number:092673953

Device Description: 60` 28V Adult Htd Limb, St Water, 40 CM Pop Off Valve, 15`

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More Product Details

Catalog Number

-

Brand Name

Heated circuit

Version/Model Number

9411

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"

Yes

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

8c7df8c2-1404-49b2-9c72-1f20bb0012dc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 20, 2017

Additional Identifiers

Package DI Number

10709078001151

Quantity per Package

18

Contains DI Package

00709078001154

Package Discontinue Date

-

Package Status

In Commercial Distribution

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