AccessGUDID - DEVICE: Integra Mishler Dual Chamber Flushing Valve (10381780072256)

GUDID

Device Identifier (DI) Information

Brand Name: Integra Mishler Dual Chamber Flushing Valve
Version or Model: NL8500312
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NL8500312
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780072256
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: VALVE FLUSH F/B D/C W/CONNECTOR The Integra Mishler Dual Chamber Flushing valve, Flat Bottom Design incorporates two separate interior chambers to provide two-way flow control when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. This silicone elastomer flushing valve is available with or without an integral Anti-Siphon Device. The flat bottom configuration eliminates the need for a formal burr hole, provides greater latitude in positioning the flushing valve and allows the ventricular catheter to be revised without disturbing the flushing valve. Due to the dual chamber feature, the proximal and distal catheters may be flushed separately or simultaneously. The flow of CSF from the ventricular catheter is controlled by a miter valve located on the vertical chamber divider. This valve is designed to open under a medium positive ventricular pressure and close under a negative pressure. The flushing valve dome is marked with an arrow to indicate the CSF flow direction. The flange overlying the skull contains sutural holes to facilitate securing the device to the periosteum.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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
K760784	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Inlet Integral Connector: 1.1 mm ID x 1.9mm OD; Outlet Integral Connector: 1.1 mm ID x 1.9 mm OD (all dimensions nominal)

Device Record Status

Public Device Record Key: 15f5e043-8ff5-47da-af97-5007aa7e8578
Public Version Date: March 18, 2024
Public Version Number: 6
DI Record Publish Date: September 22, 2015