Duns Number:134139174
Device Description: Blood Management System
Catalog Number
VJ0095
Brand Name
VAMP Jr
Version/Model Number
VJ0095
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K896819,K896819
Product Code
KRA
Product Code Name
Catheter, Continuous Flush
Public Device Record Key
917693fc-d785-4713-aaf2-6fe260b15d9c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 12, 2017
Package DI Number
50690103199661
Quantity per Package
10
Contains DI Package
00690103199666
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |