Duns Number:303639066
Device Description: VACUETTE® TUBE 10 ml Urine CCM 16x100 yellow cap-black ring, Round Base, non-ridged
Catalog Number
455052
Brand Name
VACUETTE
Version/Model Number
455052
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
db387925-0ba6-49ec-b10a-9b9aaed4d184
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
April 06, 2017
Package DI Number
39120017577325
Quantity per Package
24
Contains DI Package
29120017577328
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 |