Duns Number:878263359
Device Description: Abbott VP2000 Processor Operations Manual, Rev. D
Catalog Number
03N27-51
Brand Name
VP2000
Version/Model Number
03N27-51
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
KEY
Product Code Name
STAINER, TISSUE, AUTOMATED
Public Device Record Key
4e51dcb0-a16a-4917-9e12-1097058eac0b
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
February 20, 2015
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 | 339 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 36 |