Duns Number:303639066
Device Description: Urine CCM Set VACUETTE® Urine CCM Tube + Urine Transfer Device (454486+450751), single-pac Urine CCM Set VACUETTE® Urine CCM Tube + Urine Transfer Device (454486+450751), single-packed, Round Base, 4 ml, 13x75
Catalog Number
453031
Brand Name
VACUETTE
Version/Model Number
453031
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
JSM
Product Code Name
CULTURE MEDIA, NON-PROPAGATING TRANSPORT
Public Device Record Key
939b5506-46a2-4256-8004-b80c235c5957
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
May 18, 2017
Package DI Number
29120049206739
Quantity per Package
300
Contains DI Package
19120049206732
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 |