Catalog Number

97000HS

Brand Name

Triage

Version/Model Number

97000HS

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DDR

Product Code Name

MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

79651b51-8d7a-45c8-9c9d-073b4d8bb34c

Public Version Date

April 02, 2020

Public Version Number

2

DI Record Publish Date

November 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-