Duns Number:315016972
Device Description: The parenteral administration kit is composed to support the home application of a subcuta The parenteral administration kit is composed to support the home application of a subcutaneous injection of fluids for medical purposes.
Catalog Number
-
Brand Name
Subcutaneous Injection Supply Kit 2
Version/Model Number
900-V2US01
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
-
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
POR
Product Code Name
Parenteral Administration Kit
Public Device Record Key
3414ff78-62d0-4b43-be1c-2a8f99141176
Public Version Date
April 28, 2021
Public Version Number
2
DI Record Publish Date
September 03, 2018
Package DI Number
04046955251711
Quantity per Package
6
Contains DI Package
04046955251704
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |