Duns Number:047283094
Device Description: Urine collection kit - Urine sample collection device for basic urinalysis for dependent p Urine collection kit - Urine sample collection device for basic urinalysis for dependent patients
Catalog Number
-
Brand Name
Recopad
Version/Model Number
Medium Adult
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
OIE
Product Code Name
Urine Collection Kit (Excludes Hiv Testing)
Public Device Record Key
aaccfb25-1495-40cd-b2ff-215ee5d02bb1
Public Version Date
May 28, 2021
Public Version Number
1
DI Record Publish Date
May 20, 2021
Package DI Number
00850017881181
Quantity per Package
10
Contains DI Package
00850017881174
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |