Catalog Number

-

Brand Name

Capnovue

Version/Model Number

1001-I

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

BYG

Product Code Name

Mask, Oxygen

Public Device Record Key

e1622b5f-fbc8-4320-8dfe-e7ed06bd4c4c

Public Version Date

June 19, 2019

Public Version Number

4

DI Record Publish Date

April 25, 2017

Package DI Number

B1821001I503

Quantity per Package

50

Contains DI Package

B1821001I0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box