Duns Number:829838288
Device Description: Specimen Infusion Valve (SIV) 0.5 mm Metering Line
Catalog Number
-
Brand Name
NICO Myriad
Version/Model Number
NN-8016
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
-
Product Code
LXG
Product Code Name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Public Device Record Key
93249a39-d346-4129-b210-c27e44366164
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
September 14, 2016
Package DI Number
10816744028166
Quantity per Package
5
Contains DI Package
00816744028169
Package Discontinue Date
-
Package Status
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 62 |