Duns Number:303639066
Device Description: VACUETTE® TUBE 3.5 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-black ring, sandw VACUETTE® TUBE 3.5 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-black ring, sandwich tube, non-ridged, High- Altitude
Catalog Number
454337H
Brand Name
Vacuette
Version/Model Number
454337H
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
K971221,K971221,K971221
Product Code
GIM
Product Code Name
Tubes, vacuum sample, with anticoagulant
Public Device Record Key
f0a22cd7-4c29-4295-99e8-0d4a2f64d2c6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
39120017578926
Quantity per Package
24
Contains DI Package
29120017578929
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |