Duns Number:092815364
Device Description: This UDI represents the inner pack configuration for the Para-Pak Direct Detect product. T This UDI represents the inner pack configuration for the Para-Pak Direct Detect product. The inner pack consists of one vial per bag. The Direct Detect is a disposable specimen collection device. Clean vial in a transport bag.
Catalog Number
990125
Brand Name
Para-Pak Direct Detect
Version/Model Number
990125
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)
-
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
7d356cea-f674-4ad8-97a7-4deaa3b1dda7
Public Version Date
July 15, 2021
Public Version Number
1
DI Record Publish Date
July 07, 2021
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 | 149 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |
| 3 | A medical device with high risk that requires premarket approval | 1 |