Duns Number:303639066
Device Description: VACUETTE® TUBE 4 ml Urine CCM 13x75 yellow cap-black ring, Round Base, non-ridged
Catalog Number
454486
Brand Name
VACUETTE
Version/Model Number
454486
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
5f2c52f8-28c6-4aef-a040-8e308ebc5644
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
April 27, 2017
Package DI Number
39120049200307
Quantity per Package
24
Contains DI Package
29120049200300
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 |