Duns Number:041810693
Device Description: The Q2 Vial Adapter allows for multiple needleless access to injection medication vials fo The Q2 Vial Adapter allows for multiple needleless access to injection medication vials for transfer or withdrawl of fluids form the vial.
Catalog Number
3160
Brand Name
Q2 Vial Adapter, 20 mm
Version/Model Number
3160
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
K040634,K040634
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
4df77476-9a0d-4a3d-baa7-60f2be08ea95
Public Version Date
July 23, 2020
Public Version Number
6
DI Record Publish Date
July 14, 2016
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 168 |
| U | Unclassified | 8 |