KENOREX - ENDOTRACHEAL TUBE CUFFED 6.5 MM WITH STYLET - KENTRON HEALTHCARE, INC.

Duns Number:618825723

Device Description: ENDOTRACHEAL TUBE CUFFED 6.5 MM WITH STYLET MURPHY EYE

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More Product Details

Catalog Number

769965

Brand Name

KENOREX

Version/Model Number

769965

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K042683,K042683,K042683

Product Code Details

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Device Record Status

Public Device Record Key

535670a6-809d-49bd-926d-df6dbb5c7c32

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 10, 2016

Additional Identifiers

Package DI Number

20851785007494

Quantity per Package

10

Contains DI Package

30851785007491

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"KENTRON HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 155