Catalog Number

-

Brand Name

UNI-LIM Coaxial Circuit

Version/Model Number

8102

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

K922492,K922492

Product Code

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Public Device Record Key

43d97a18-c9bd-4b10-952c-92007be38864

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

May 25, 2020

Package DI Number

10709078008464

Quantity per Package

20

Contains DI Package

00709078008467

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-