Duns Number:809699023
Device Description: NAMIC 10" clearaCIL Contrast Injection Line, Female to Male Luer Lock
Catalog Number
-
Brand Name
NAMIC
Version/Model Number
81031102
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
21d950d7-a86d-43a3-a844-d962d2c3cca7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2015
Package DI Number
H749810311021
Quantity per Package
100
Contains DI Package
H749810311020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 71 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1641 |