Duns Number:785335381
Device Description: E8 Combination Centrifuge, variable speed, for 3-15ml test tubes and 75mm hematocrit tubes E8 Combination Centrifuge, variable speed, for 3-15ml test tubes and 75mm hematocrit tubes, with crit carrier and reader card
Catalog Number
-
Brand Name
E8 Combination Centrifuge, variable speed
Version/Model Number
E8C-U8AV-CC03
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GKG
Product Code Name
Centrifuge, Hematocrit
Public Device Record Key
b20191d1-cc04-4da8-8c8b-b8f2c44a9796
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 01, 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 | 94 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |