Catalog Number

33035-12-CAP

Brand Name

ClearView Nasal Mask and Capnography Bundle – Adult Birthday Bubblegum (pkg.12)

Version/Model Number

33035-12-CAP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 10, 2199

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

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

KHA

Product Code Name

Mask, Scavenging

Public Device Record Key

3da59c91-75ce-44b1-9d54-4b5f154df468

Public Version Date

August 18, 2020

Public Version Number

1

DI Record Publish Date

August 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-