Duns Number:508663101
Device Description: When implemented together with CellaVision DM9600 and software, the CellaVision Advanced R
Catalog Number
CAR-970099
Brand Name
CellaVision® Advanced RBC Application DM9600
Version/Model Number
CAR-970099
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
K171315
Product Code
JOY
Product Code Name
Device, Automated Cell-Locating
Public Device Record Key
3460c27f-b631-40d3-8878-b46bed3a9c33
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
March 05, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |