Duns Number:463720681
Device Description: QUICKPIN is a luer-lock spike used in manual or automated pharmacy compounding for additio QUICKPIN is a luer-lock spike used in manual or automated pharmacy compounding for addition and/or extraction of IV substances from rubber stoppered containers including multi-dose vials.
Catalog Number
-
Brand Name
QUICKPIN
Version/Model Number
QUICKPIN
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
K082752,K082752,K082752
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
a5eae159-7c74-4c7f-8e48-842212c49665
Public Version Date
August 09, 2019
Public Version Number
4
DI Record Publish Date
April 05, 2017
Package DI Number
38426314734562
Quantity per Package
4
Contains DI Package
28426314734565
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |