Duns Number:841522985
Device Description: NRHZ: A sterile device designed to be securely attached to the septum end of a vial to cre NRHZ: A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial's sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial's contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device.
Catalog Number
10
Brand Name
Summit Medical
Version/Model Number
R001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2023
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)
-
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
f592e766-4f63-4005-b93c-396ee487f7a5
Public Version Date
October 04, 2018
Public Version Number
1
DI Record Publish Date
September 03, 2018
Package DI Number
B346R00129
Quantity per Package
50
Contains DI Package
B346R0011
Package Discontinue Date
December 31, 2023
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. | 14 |