Duns Number:080278407
Device Description: 100 Disposable Plastic Urine Specimen Cups
Catalog Number
-
Brand Name
Easy@Home Disposable Plastic Urine Cup (100- pack)
Version/Model Number
EZW-LH3C100
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
153b1793-1fe3-4949-9d81-c4ddddb287a8
Public Version Date
August 01, 2018
Public Version Number
1
DI Record Publish Date
July 01, 2018
Package DI Number
10855944007366
Quantity per Package
24
Contains DI Package
00855944007369
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 47 |