Duns Number:303639066
Device Description: VACUETTE® TUBE 3ml 9NC Coagulation sodium citrate 3.2% 13x75 light blue cap-black Ring, sa VACUETTE® TUBE 3ml 9NC Coagulation sodium citrate 3.2% 13x75 light blue cap-black Ring, sandwich tube, non-ridged, Canada
Catalog Number
454334CA
Brand Name
Vacuette
Version/Model Number
454334CA
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
71499e6b-202d-4988-82ab-7804b8bea007
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
39120017576380
Quantity per Package
24
Contains DI Package
29120017576383
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 |