30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW, AND LIMB, 2.4M - 30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER - Intersurgical Incorporated

Duns Number:785952607

Device Description: 30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW, AND LIMB, 2.4M

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More Product Details

Catalog Number

-

Brand Name

30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW, AND LIMB, 2.4M

Version/Model Number

2901000

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"

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 Details

Product Code

CAI

Product Code Name

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

Device Record Status

Public Device Record Key

06f2dd52-d93b-43f5-9de7-5d72a89871df

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

October 15, 2021

Additional Identifiers

Package DI Number

05030267029020

Quantity per Package

10

Contains DI Package

05030267065363

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INTERSURGICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 101