Duns Number:303639066
Device Description: Urine CCM / Z Urine No Additive Set with Beaker <(>&<)> Towelette consisting of: Item No. Urine CCM / Z Urine No Additive Set with Beaker <(>&<)> Towelette consisting of: Item No. 454486 VACUETTE® TUBE 4 ml Urine CCM, 13x75, Round Base Item No. 455028 VACUETTE® TUBE 9 ml Z Urine No Additive, 16x100, Conical Base Item No. 724310 Urine Beaker with integrated Transfer Device 100 ml Castile Soap Towelette single-packed
Catalog Number
-
Brand Name
VACUETTE
Version/Model Number
453042
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
209d403d-38c8-4c7a-b16f-104ce4e96ca4
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
January 16, 2020
Package DI Number
29120049209082
Quantity per Package
50
Contains DI Package
19120049209085
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 |