Duns Number:796269165
Device Description: POWERSPIN™ BX CENTRIFUGE, VARIABLE SPEED 1,000-13,000 RPM WITH 8 PLACE TUBE ROTOR, 24 PLAC POWERSPIN™ BX CENTRIFUGE, VARIABLE SPEED 1,000-13,000 RPM WITH 8 PLACE TUBE ROTOR, 24 PLACE MICROHEMATOCRIT ROTOR AND 24 PLACE MICROCENTRIFUGE ROTOR, 110 V
Catalog Number
C885
Brand Name
UNICO POWERSPIN BX
Version/Model Number
C885
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
d8aef4af-388c-4d18-9bfa-557ad6145ac3
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
April 10, 2017
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |