70 Brain Microdialysis Catheter 100/10, 4/pkg

Basic Information

• Brand Name: 70 Brain Microdialysis Catheter 100/10, 4/pkg
• Primary DI: 07332699000928
• Version / Model: 100/10
• Catalog Number: P000050
• Company Name: M DIALYSIS INC.
• Labeler DUNS: 824632087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2019-10-07
• Public Version Status: Update
• Public Device Record Key: 6ffc6027-7506-48af-8df4-f55fc5397ee6

Device Description

Microdialysis catheter (20 kDa cut-off, 100 mm shaft length, 10 mm membrane length) for short term brain insertion using a tunnelation technique.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
GWM	Device, Monitoring, Intracranial Pressure	Neurology	882.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45469	Microdialysis system catheter	A thin, flexible tube intended to be inserted/implanted into tissue (e.g., brain, liver, muscle) as part of a system used to monitor local tissue chemistry for the early detection of metabolic imbalances and/or cell damage, typically after surgery or during a metabolic disorder. The device has a semi-permeable membrane at its distal end for the diffusion of interstitial fluid to obtain a dialysate sample for analysis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07332699000539	GS1	White cardboard box	4	In Commercial Distribution
Primary	07332699000928	GS1

Device Sizes

Type	Value	Unit	Text
Length	10	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius