Catalog Number

19932-BKH

Brand Name

HUDSON RCI

Version/Model Number

IPN043835

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

K964382,K964382

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

017a1d18-b147-4504-8b2e-b6abee22f838

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

24026704581478

Quantity per Package

20

Contains DI Package

04026704581474

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Case