Duns Number:607846297
Device Description: CODMAN HAKIM Precision Fixed Pressure Valve with Proximal Tubing and .060 Inch Platform Op CODMAN HAKIM Precision Fixed Pressure Valve with Proximal Tubing and .060 Inch Platform Operating Pressure: 100mm H2O Medium High Range Includes: HOLTER Type "B" Connector, Straight Connector, Priming Adapter and information Manual
Catalog Number
NS0512
Brand Name
CODMAN HAKIM HOLTER
Version/Model Number
NS0512
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2022
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
K053350
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
1bbf3189-aa16-4a5d-a9d6-1b39ad3a1d9f
Public Version Date
September 01, 2022
Public Version Number
5
DI Record Publish Date
September 20, 2015
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1054 |
| 3 | A medical device with high risk that requires premarket approval | 11 |