Duns Number:149183167
Device Description: Plasma Separator
Catalog Number
2113-0013
Brand Name
VitaPrep
Version/Model Number
2113-0013
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2018
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P050044,P050044,P050044,P050044
Product Code
LMF
Product Code Name
Agent, absorbable hemostatic, collagen based
Public Device Record Key
d6aa766b-49d9-4310-8f8b-1cd79d10d1c2
Public Version Date
April 23, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2014
Package DI Number
30808232001243
Quantity per Package
5
Contains DI Package
00808232001242
Package Discontinue Date
June 30, 2018
Package Status
Not in Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2688 |
2 | A medical device with a moderate to high risk that requires special controls. | 5304 |
3 | A medical device with high risk that requires premarket approval | 86 |