Duns Number:926603486
Device Description: The urine collection cup is a sterile plastic cup with a temperature strip and leak-resist The urine collection cup is a sterile plastic cup with a temperature strip and leak-resistant lid with a capacity of 90mL. This product can be used for urine, blood, and semen sample testing.
Catalog Number
DU3100
Brand Name
Sterile Specimen Cup with Temp Strip
Version/Model Number
1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMH
Product Code Name
Container, Specimen, Sterile
Public Device Record Key
ada65324-a0a2-4d6f-a0f3-a5508ca50f51
Public Version Date
August 21, 2020
Public Version Number
1
DI Record Publish Date
August 13, 2020
Package DI Number
10850014433236
Quantity per Package
100
Contains DI Package
00850014433239
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |