Duns Number:080935429
Device Description: Blood Collection Tube,Silicone Coated Tube, Silicone Coated Royal Blue Stopper, No Additiv Blood Collection Tube,Silicone Coated Tube, Silicone Coated Royal Blue Stopper, No Additive, 7 mL Draw
Catalog Number
8881307006
Brand Name
Monoject
Version/Model Number
8881307006
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
-
Product Code
JKA
Product Code Name
Tubes, vials, systems, serum separators, blood collection
Public Device Record Key
16420822-1ff7-4024-b378-ab926f25e0a0
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
30884527002973
Quantity per Package
1000
Contains DI Package
10884527002979
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |