Duns Number:841522985
Device Description: Product consist of piercing spike and cover, the twist off-connector and an integrated via Product consist of piercing spike and cover, the twist off-connector and an integrated vial adaptor for access to drugs/solution vials. Indicated to serve as a connecting port between IV bag and external IV line.
Catalog Number
R002
Brand Name
Summit International
Version/Model Number
R002
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 30, 2024
Issuing Agency
In HIBCC
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
a164fc6f-6794-4da6-b9b4-cf8039b5f13b
Public Version Date
October 10, 2022
Public Version Number
2
DI Record Publish Date
May 03, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |