Duns Number:388240673
Device Description: The BCS Cuvette Rotor is part of the BCS-XP system.
Catalog Number
OVIP15
Brand Name
BCS® System Cuvette Rotors
Version/Model Number
10446524
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K970431,K970431
Product Code
GKP
Product Code Name
INSTRUMENT, COAGULATION, AUTOMATED
Public Device Record Key
4f2122d2-e5a8-45f7-8a66-4129f11884c0
Public Version Date
September 16, 2022
Public Version Number
6
DI Record Publish Date
October 31, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |