BREATHING SYSTEM TUBE SUPPORT FOR INTERSURGICAL 15MM, 22MM AND 30MM TUBING - BREATHING SYSTEM TUBE SUPPORT FOR INTERSURGICAL - Intersurgical Incorporated

Duns Number:785952607

Device Description: BREATHING SYSTEM TUBE SUPPORT FOR INTERSURGICAL 15MM, 22MM AND 30MM TUBING

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More Product Details

Catalog Number

-

Brand Name

BREATHING SYSTEM TUBE SUPPORT FOR INTERSURGICAL 15MM, 22MM AND 30MM TUBING

Version/Model Number

5904000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

JAY

Product Code Name

Support, Breathing Tube

Device Record Status

Public Device Record Key

43654df6-9508-48e1-8ba3-47091114d311

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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