QFlow 500 Perfusion Probe

Basic Information

• Brand Name: QFlow 500 Perfusion Probe
• Primary DI: B238H000016000
• Version / Model: NA
• Catalog Number: H0000-1600
• Company Name: HEMEDEX, INC
• Labeler DUNS: 128045676
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 786891c5-b814-4095-b6f9-f42343660934

Device Description

Thermal Diffusion Probe

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	870.2100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45552	Patient monitoring system module, intracranial pressure	A small unit dedicated to the detection, measurement, and recording of intracranial pressure (ICP). It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the parameter/information measured and provided by this module.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B238H000016000	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K013376	000