Catalog Number

-

Brand Name

SourceMark

Version/Model Number

M1026

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

9be1f0ca-b17d-4fb5-8dce-a05e103b4316

Public Version Date

July 17, 2020

Public Version Number

1

DI Record Publish Date

July 09, 2020

Package DI Number

10813799006057

Quantity per Package

10

Contains DI Package

00813799006043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box