Catalog Number

-

Brand Name

Firstar

Version/Model Number

FS-104

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

-

FDA Premarket Submission

K083418,K083418

Product Code

CBP

Product Code Name

Valve, Non-Rebreathing

Public Device Record Key

068f715f-f542-45fe-a2a5-79c924e0e9ab

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 06, 2017

Package DI Number

B448FS1042

Quantity per Package

50

Contains DI Package

B448FS1041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case