Duns Number:081277700
Device Description: In-Line Valve SIPHONGUARD® Device, .060" Platform and Unitized Distal Catheter
Catalog Number
82-3854
Brand Name
HAKIM® SIPHONGUARD® HOLTER
Version/Model Number
823854
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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,K053350
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
ef2b1341-63c3-4c04-a297-24dcd001c0d3
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
June 02, 2020
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 | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |