Duns Number:303639066
Device Description: VACUETTE® TUBE 4 ml FX Sodium Fluoride / Potassium Oxalate 13x75 grey cap-black ring, non- VACUETTE® TUBE 4 ml FX Sodium Fluoride / Potassium Oxalate 13x75 grey cap-black ring, non-ridged, Canada
Catalog Number
454297CA
Brand Name
Vacuette
Version/Model Number
454297CA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2017
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
K971239,K971239,K971239
Product Code
JKA
Product Code Name
Tubes, vials, systems, serum separators, blood collection
Public Device Record Key
500b42ce-dfdd-4b1f-988c-808ebdf1ed88
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
39120017579961
Quantity per Package
24
Contains DI Package
29120017579964
Package Discontinue Date
October 31, 2017
Package Status
Not 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 |