Catalog Number

-

Brand Name

Disposable Anesthesia Circuit

Version/Model Number

8081

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

CAI

Product Code Name

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

Public Device Record Key

62110463-b126-449c-95e1-36e7b94124d3

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

July 31, 2019

Package DI Number

10709078007641

Quantity per Package

20

Contains DI Package

00709078007644

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-