AccessGUDID - DEVICE: H-V Lumbar Valve System (10381780035381)

GUDID

Device Identifier (DI) Information

Brand Name: H-V Lumbar Valve System
Version or Model: 903335A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 903335A
Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Primary DI Number: 10381780035381
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 531408342 *Terms of Use

Device Description: The Horizontal-Vertical Lumbar Valve System is an implantable device that provides controlled intraventricular pressure and cerebrospinal fluid (CSF) drainage from the lumbar subarachnoid region to the peritoneal cavity. The system minimizes overdrainage by automatically compensating for changes in CSF hydrostatic pressure when the patient changes from a recumbent to an upright position. Available in different closing pressure ranges (according horizontal and vertical orientations).

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
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.	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 [?]
K101381	000
K161992	000
K944595	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: Closing Pressure Range (YELLOW) Horizontal: 85-125mmH2O / Vertical: 265-365mmH2O, Distal Cath. 91cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Lumb. Cath. 80cm Length x 1.6mm O.D. x 0.8mm I.D. (F5)

Device Record Status

Public Device Record Key: 654b19c9-aa7a-46c4-9c90-02c79dc74233
Public Version Date: March 18, 2024
Public Version Number: 5
DI Record Publish Date: October 01, 2015