Catalog Number

HCS64184

Brand Name

Medline

Version/Model Number

HCS64184

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

K023683

Product Code

CBP

Product Code Name

Valve, non-rebreathing

Public Device Record Key

52b30f82-f732-4cfe-83ac-a60d634e3851

Public Version Date

November 13, 2020

Public Version Number

1

DI Record Publish Date

November 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-