Catalog Number

70530

Brand Name

Hsiner

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"

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

K091185,K091185

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

54d52b76-43f5-409d-8d4f-e75448d738a9

Public Version Date

September 22, 2020

Public Version Number

2

DI Record Publish Date

July 13, 2020

Package DI Number

14712680057436

Quantity per Package

100

Contains DI Package

04712688057431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton