Catalog Number

-

Brand Name

30MM UNIFLOW COAXIAL BS WITH ELBOW INTEGRAL MONITORING LINE AND LIMB, 1.6M

Version/Model Number

2902000

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

CAI

Product Code Name

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

Public Device Record Key

53197989-752a-40fe-97d2-628f744ab8b7

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

October 15, 2021

Package DI Number

05030267029846

Quantity per Package

12

Contains DI Package

05030267065431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-