Catalog Number

-

Brand Name

Uni-Lim Coaxial Circuit

Version/Model Number

9695

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

e4edc008-a82e-4c09-9bfc-34c852092176

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

October 08, 2021

Package DI Number

10709078013666

Quantity per Package

20

Contains DI Package

00709078013669

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case