MedSource ET Tube, 3.5mm, Cuffed w/Stylet - ET Tube, 3.5mm, Cuffed w/Stylet - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: ET Tube, 3.5mm, Cuffed w/Stylet

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More Product Details

Catalog Number

-

Brand Name

MedSource ET Tube, 3.5mm, Cuffed w/Stylet

Version/Model Number

MS-23435

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"

-

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

-

Product Code Details

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Device Record Status

Public Device Record Key

3b1dc0b3-2638-43a4-8cec-354a28e1ff68

Public Version Date

April 25, 2022

Public Version Number

4

DI Record Publish Date

June 17, 2016

Additional Identifiers

Package DI Number

10816703020316

Quantity per Package

10

Contains DI Package

00816703020319

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90