Duns Number:119214195
Device Description: hemochroma PLUS Optical System Check is intended to assure the performance of the optic sy hemochroma PLUS Optical System Check is intended to assure the performance of the optic system of the hemochroma PLUS Analyzer.
Catalog Number
100-404
Brand Name
hemochroma PLUS Optical System Check
Version/Model Number
100-404
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
6f069f11-af00-4221-a62c-fb47d9425410
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 |