Catalog Number

-

Brand Name

Uni-lim Coaxial Circuit

Version/Model Number

9415

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

-

Product Code

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

573ee752-e50f-48b9-8942-66620853020e

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

July 24, 2019

Package DI Number

10709078007580

Quantity per Package

20

Contains DI Package

00709078007583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-