Duns Number:119214195
Device Description: The hemochroma PLUS Analyzer calculates the test result automatically and displays hemoglo The hemochroma PLUS Analyzer calculates the test result automatically and displays hemoglobin concentration in terms of g/dL.
Catalog Number
100-101
Brand Name
hemochroma PLUS Analyzer
Version/Model Number
100-101
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
-
Product Code
GKR
Product Code Name
SYSTEM, HEMOGLOBIN, AUTOMATED
Public Device Record Key
6472ba98-1ac0-4199-b32b-ed31d8bf2c69
Public Version Date
January 21, 2019
Public Version Number
1
DI Record Publish Date
December 20, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |