Integra Flow Regulating Valve Low Flow

Basic Information

• Brand Name: Integra Flow Regulating Valve Low Flow
• Primary DI: 10381780033820
• Version / Model: 909510
• Catalog Number: 909510
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Labeler DUNS: 531408342
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-01
• Public Version: 5
• Public Version Date: 2023-02-09
• Public Version Status: Update
• Public Device Record Key: 60873690-08cd-4707-aa51-6a5ad7fd136c
• Distribution End Date: 2021-12-31

Device Description

The Integra Flow Regulating Valves Low Flow Lumbar are implantable hydrocephalus valve systems for controlled cerebrospinal fluid (CSF) drainage from the lumbar subarachnoid region to the peritoneal cavity. Unlike conventional valves, the Integra Flow Regulating Valve Low Flow is a variable resistance valve that maintains drainage at a constant rate, between 8 and 17 ml/hr, within the physiological range of intracranial pressure.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61523	Lumboperitoneal shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine to the peritoneal cavity where it can be absorbed into the body, as a treatment for raised CSF pressure (e.g., caused by hydrocephalus). It consists of fully-implantable interconnected components: a spinal catheter implanted into subarachnoid space of the lumbar spine; a mechanical shunt valve that may incorporate a puncturable port/reservoir for sampling/infusion; a peritoneal catheter implanted into the peritoneal cavity; some types incorporate a subcutaneous anchor for component connection/positioning. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780033820	GS1
Secondary	M2729095101	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092395	000
K140722	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Flow Regulation Valve: 8-17ml/h, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Lumbar Cath. 80cm Length x 1.6mm O.D. x 0.8mm I.D. (F5), 14G Tuohy Needle, F8-F5 Stepdown Connector

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room temperature