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

0b6a4112-46a6-4447-bf99-6935988646a6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 17, 2017

Package DI Number

50748426075107

Quantity per Package

10

Contains DI Package

00748426075102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-