Catalog Number

-

Brand Name

SourceMark

Version/Model Number

M1018

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Product Code

BTQ

Product Code Name

Airway, Nasopharyngeal

Public Device Record Key

472140cc-fcf2-4350-8c3c-390b493d267b

Public Version Date

July 09, 2020

Public Version Number

5

DI Record Publish Date

August 26, 2016

Package DI Number

10897392004214

Quantity per Package

10

Contains DI Package

00897392001957

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box