Duns Number:086645029
Device Description: Multi-panel Drug Test Cup
Catalog Number
PF12P
Brand Name
Preferred Med Supply
Version/Model Number
PF12P
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
K182654,K182654,K182654,K182654
Product Code
NFT
Product Code Name
Test, Amphetamine, Over The Counter
Public Device Record Key
3ad277b5-1210-4531-8f4c-bd6f5162fedf
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
August 11, 2021
Package DI Number
00860004081616
Quantity per Package
3
Contains DI Package
00860004081609
Package Discontinue Date
December 31, 2021
Package Status
Not in Commercial Distribution
Package Type
Box