Duns Number:169260325
Device Description: 20mm Multi-Dose Vial Access Device
Catalog Number
-
Brand Name
IV Plus®
Version/Model Number
N0601A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 26, 2017
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"
Yes
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
K080976,K080976
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
a2f67e17-25de-4d7b-ae6e-8e1b6c7cb75b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
30892855000806
Quantity per Package
50
Contains DI Package
10892855000802
Package Discontinue Date
April 26, 2017
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 180 |