Catalog Number

-

Brand Name

MICROTEK

Version/Model Number

1

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K950769,K950769

Product Code

CBP

Product Code Name

Valve, non-rebreathing

Public Device Record Key

26a45d92-ef65-450c-a962-fab171d7b28c

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

April 26, 2017

Package DI Number

50748426120395

Quantity per Package

10

Contains DI Package

00748426120390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-