Duns Number:019410187
Device Description: iCUP Rx 5 Drug w/SVT (pH, SG, OX, CR,NI) (BZO300/BUP10/MTD300/OPI300/OXY100)
Catalog Number
I-RXA-157-01
Brand Name
Alere iCup RX
Version/Model Number
I-RXA-157-01
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133968
Product Code
DJG
Product Code Name
Enzyme Immunoassay, Opiates
Public Device Record Key
6fc296d6-a90c-472d-933b-b4c7ba63940a
Public Version Date
October 31, 2022
Public Version Number
8
DI Record Publish Date
April 21, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 122 |
| U | Unclassified | 1 |