Duns Number:029062325
Device Description: Plasma/Fluid Transfer Set 12mL Monoject™ Syringe and Adapter Cap Assembly
Catalog Number
03-220-BC12
Brand Name
N/A
Version/Model Number
03-220-BC12
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK050021,BK050021
Product Code
KSB
Product Code Name
Set, Transfer (Blood/Plasma)
Public Device Record Key
d20e7b15-975a-45b6-96e8-e46fa81e61ea
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
00817827021596
Quantity per Package
96
Contains DI Package
00817827021091
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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. | 75 |
| U | Unclassified | 7 |