Duns Number:198063752
Device Description: PharmChek® is a drug sweat patch worn on the skin surface for up to 10 days or longer that PharmChek® is a drug sweat patch worn on the skin surface for up to 10 days or longer that acts as a specimen container for the non-volatile and liquid components of sweat.
Catalog Number
-
Brand Name
PharmChek (R) Drugs of Abuse Sweat Patch
Version/Model Number
Single Patch
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
581a6ae6-5c1b-4749-8430-0edfdf668e69
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
June 30, 2019
Package DI Number
00860001701029
Quantity per Package
50
Contains DI Package
00860001701005
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box of 50
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |