Catalog Number

-

Brand Name

DAR

Version/Model Number

111P1160

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

CAI

Product Code Name

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

Public Device Record Key

8f8e76fc-7785-49ff-9abb-892c2c16bd37

Public Version Date

September 13, 2022

Public Version Number

4

DI Record Publish Date

August 07, 2019

Package DI Number

20884521784670

Quantity per Package

10

Contains DI Package

10884521784673

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE