Catalog Number

157

Brand Name

Halyard

Version/Model Number

93821

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102483,K102483,K102483

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

33bc5d4a-8fb7-42e6-a560-c818ca81cef9

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

30609038000771

Quantity per Package

25

Contains DI Package

10680651938210

Package Discontinue Date

April 12, 2017

Package Status

Not in Commercial Distribution

Package Type

CS