Catalog Number

-

Brand Name

Capette

Version/Model Number

CP-4203

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

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

JAY

Product Code Name

Support, Breathing Tube

Public Device Record Key

9e707a58-2836-4fea-8557-4be0fe2a359e

Public Version Date

July 05, 2021

Public Version Number

1

DI Record Publish Date

June 25, 2021

Package DI Number

10709078013017

Quantity per Package

40

Contains DI Package

00709078013010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case