SourceMark - Tube, Endo, Oral and Nasal, Murphy, Cuffed 7.0 + - SOURCEMARK, LLC.

Duns Number:121225812

Device Description: Tube, Endo, Oral and Nasal, Murphy, Cuffed 7.0 + Stylet, Aluminum

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More Product Details

Catalog Number

-

Brand Name

SourceMark

Version/Model Number

MX0470C

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

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

390bbaa6-2a6a-4f03-8a9e-a60d478f30a0

Public Version Date

July 09, 2020

Public Version Number

7

DI Record Publish Date

August 26, 2016

Additional Identifiers

Package DI Number

10897392004375

Quantity per Package

10

Contains DI Package

00897392002312

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SOURCEMARK, LLC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 71