Catalog Number

HC-117

Brand Name

Hemoglobin AE Control

Version/Model Number

HC-117

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

K802569,K802569

Product Code

KHG

Product Code Name

Whole Blood Hemoglobin Determination

Public Device Record Key

81ddd88a-f75d-47ee-bbac-4e37714c11c8

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 31, 2019

Package DI Number

10817869020202

Quantity per Package

6

Contains DI Package

00817869020205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

6 pack