DEVICE: Natus® (00382830056526)
Device Identifier (DI) Information
Natus®
NT8500108
In Commercial Distribution
NT8500108
NATUS MEDICAL INCORPORATED
NT8500108
In Commercial Distribution
NT8500108
NATUS MEDICAL INCORPORATED
Multi-Purpose Valve (Medium Pressure) with Anti-Siphon Device
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35965 | Cerebrospinal fluid shunt valve |
An implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of synthetic polymer and/or metallic materials; it does not incorporate a port or reservoir. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JXG | Shunt, Central Nervous System And Components |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K153041 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Inlet Tube: 1.2mm ID x 2.2mm OD; Outlet Tube: 1.2mm ID x 2.2mm OD |
Device Record Status
46952ccd-3b50-4983-bb8d-57576cdbdf0e
February 20, 2025
3
April 17, 2020
February 20, 2025
3
April 17, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-356-0007
Madison.Helpdesk@Natus.com
Madison.Helpdesk@Natus.com