DVM 4500

Basic Information

• Brand Name: DVM 4500
• Primary DI: 00894912002180
• Version / Model: DVM 4500
• Catalog Number: DVM 4500
• Company Name: KOVEN TECHNOLOGY, INC.
• Labeler DUNS: 069261402
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 12c2cc7f-4060-481f-b09a-9285986dcb5d

Device Description

Doppler blood flowmeter.

Device Characteristics

• Single Use: No
• 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: No
• Has Manufacturing Date: No
• 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
61227	Invasive vascular ultrasound system	A mains electricity (AC-powered) device assembly designed to invasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) using ultrasound/Doppler/transit time technology during procedures involving vascular surgery. It may also provide additional measurements (e.g., blood pressure, vascular resistance). It consists of a mobile (on wheels) control unit with graphical user-interface, typically placed outside the sterile field; and an attached, reusable, sterilizable probe intended to be used within the body (invasive) but not within the lumen of the blood vessel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00894912002180	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K892707	000