CO2 Sampling Nasal Cannula - CO2 Sampling Nasal Cannula (Healthcare Logistics) - WESTMED, INC.

Duns Number:092673953

Device Description: CO2 Sampling Nasal Cannula (Healthcare Logistics)

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More Product Details

Catalog Number

-

Brand Name

CO2 Sampling Nasal Cannula

Version/Model Number

2100-50

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

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Device Record Status

Public Device Record Key

11f48d8a-71b9-43d1-b1b6-ce48e02d5f4a

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

May 03, 2017

Additional Identifiers

Package DI Number

10709078003940

Quantity per Package

50

Contains DI Package

00709078003943

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