Catalog Number

M15001

Brand Name

Mast Assure

Version/Model Number

M15001

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GSQ

Product Code Name

Antiserum, Vibrio Cholerae, All Varieties

Public Device Record Key

5a77b6df-2472-4575-955c-2d10cc97b781

Public Version Date

June 04, 2018

Public Version Number

1

DI Record Publish Date

May 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-