Duns Number:557223252
Device Description: ChemSTAT Hematocrit Evaluator 2, 10 ampoules x 1.8 mL
Catalog Number
00044000105
Brand Name
ChemSTAT Hematocrit Evaluator 2
Version/Model Number
00044000105
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
-
Product Code
GLK
Product Code Name
Control, Hematocrit
Public Device Record Key
86565820-38a1-4ad4-8b43-eafb32f0818f
Public Version Date
July 13, 2021
Public Version Number
3
DI Record Publish Date
June 26, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 272 |