Catalog Number

-

Brand Name

Mission Plus Hemoglobin (Hb) Test Cartridges

Version/Model Number

C132-3021

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

K122553,K122553,K122553

Product Code

GKR

Product Code Name

SYSTEM, HEMOGLOBIN, AUTOMATED

Public Device Record Key

bdec9505-ffa1-48e1-b0c6-33aae642d33a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20682607610536

Quantity per Package

130

Contains DI Package

00682607610532

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton