CO2/O2 Nasal Cannula - 10' with reflective luer - WESTMED, INC.

Duns Number:092673953

Device Description: 10' with reflective luer

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More Product Details

Catalog Number

-

Brand Name

CO2/O2 Nasal Cannula

Version/Model Number

0912

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

2f838a70-b75e-4fac-aab9-1fa1bf17cb1b

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

June 25, 2018

Additional Identifiers

Package DI Number

10709078005326

Quantity per Package

25

Contains DI Package

00709078005329

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