Catalog Number

-

Brand Name

Mapleson Anesthesia Breathing Circuit

Version/Model Number

10-80367

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

940ae954-0a05-4b2d-9b34-f756a94aefbf

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

January 31, 2018

Package DI Number

30641043803671

Quantity per Package

20

Contains DI Package

10641043803677

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-