Duns Number:303639066
Device Description: Urine Cup with integrated Transfer Device 100 ml bulk-packed, non-sterile
Catalog Number
724322
Brand Name
Vacuette
Version/Model Number
724322
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
NNI
Product Code Name
CONTAINER, SPECIMEN, NON-STERILE
Public Device Record Key
dbdd1811-adda-4767-b5c8-c9930f57f952
Public Version Date
June 27, 2022
Public Version Number
1
DI Record Publish Date
June 18, 2022
Package DI Number
39120049208624
Quantity per Package
300
Contains DI Package
19120049208620
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 |