DOPPLER MODEL 810-A KIT

Basic Information

• Brand Name: DOPPLER MODEL 810-A KIT
• Primary DI: 00816787020182
• Version / Model: 810-A
• Company Name: PARKS MEDICAL ELECTRONICS, INC.
• Labeler DUNS: 009041773
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 6807dab4-8209-4884-b431-6acfeff22ebc

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DPW	FLOWMETER, BLOOD, CARDIOVASCULAR	Cardiovascular	870.2100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60451	Laser Doppler blood flowmeter	A mobile, mains electricity (AC-powered) device designed to use laser Doppler techniques to measure the velocity of micro- and macrovascular blood circulation to assess of the extent of vascular flow restrictions [e.g., clots, stenosis, mechanical damage, and peripheral vascular disease (PVD)]. It typically measures blood flow/perfusion, transcutaneous oxygen (TCOM) and/or carbon dioxide, and may have modules for heat provocation and pressure control. It typically consists of various laser Doppler probes, temperature measurement sensors, and pressure measuring cuff/sensors connected to a software-controlled control/visual display unit.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816787020182	GS1

Customer Contacts

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