Catalog Number

-

Brand Name

Mission Plus Hemoglobin (Hb) Optical Verifier

Version/Model Number

C122-3021

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

-

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

9da8ada0-4f30-46e4-9ba1-617c2a6100fc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20682607610567

Quantity per Package

200

Contains DI Package

00682607610563

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton