Catalog Number

47MSF8-14-13

Brand Name

CapnoVue

Version/Model Number

47MSF8-14-13

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K151421,K151421

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

e04f2546-b152-4f7a-9054-af584f21dca0

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

January 27, 2020

Package DI Number

10607411971393

Quantity per Package

50

Contains DI Package

00607411971396

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-