Catalog Number

-

Brand Name

LSP

Version/Model Number

L64186

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K010191,K010191

Product Code

CBP

Product Code Name

Valve, Non-Rebreathing

Public Device Record Key

f78266c3-eed6-42ae-a167-98498754858f

Public Version Date

May 13, 2020

Public Version Number

5

DI Record Publish Date

August 25, 2016

Package DI Number

40026072022991

Quantity per Package

12

Contains DI Package

00026072022993

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case