Duns Number:328712260
Device Description: MassCheck® Ethyl Glucuronide, Ethyl Sulfate, Urine Control Level III
Catalog Number
0369
Brand Name
Urine Control
Version/Model Number
0369
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
-
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
DKC
Product Code Name
Alcohol Control Materials
Public Device Record Key
fa741399-314a-4ac7-bbfd-e6944d8ab7d3
Public Version Date
August 14, 2020
Public Version Number
1
DI Record Publish Date
August 06, 2020
Package DI Number
04250317535795
Quantity per Package
5
Contains DI Package
04250317546111
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 | 455 |
2 | A medical device with a moderate to high risk that requires special controls. | 92 |