Duns Number:809699023
Device Description: NAMIC Standard Peripheral Vascular Angiographic Kit Protection Station Plus with Syringes NAMIC Standard Peripheral Vascular Angiographic Kit Protection Station Plus with Syringes and flexCIL
Catalog Number
-
Brand Name
NAMIC
Version/Model Number
91310330
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
DTL
Product Code Name
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Public Device Record Key
3118e37b-65f4-4342-bf57-d43b1f4d4f88
Public Version Date
May 07, 2019
Public Version Number
3
DI Record Publish Date
September 17, 2015
Package DI Number
H749913103301
Quantity per Package
10
Contains DI Package
H749913103300
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 |