Circuit - Universal disposable circuit with filter - RESMED PTY LTD

Duns Number:751149311

Device Description: Universal disposable circuit with filter

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

21952

Brand Name

Circuit

Version/Model Number

21952

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

CAI

Product Code Name

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

Device Record Status

Public Device Record Key

8bbc0560-721d-4480-938a-43aac8fdc0d6

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

May 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESMED PTY LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 54
2 A medical device with a moderate to high risk that requires special controls. 841