Cook-Swartz

Basic Information

• Brand Name: Cook-Swartz
• Primary DI: 00827002213630
• Version / Model: G21363
• Catalog Number: DP-SDP001
• Company Name: Cook Vandergrift Inc.
• Labeler DUNS: 056867526
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2018-09-12
• Public Version Status: Update
• Public Device Record Key: b78d9620-47b7-48af-82e7-a5af91095a53

Device Description

Cook-Swartz Doppler Flow Probe Standard Cuff

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
JOP	TRANSDUCER, ULTRASONIC	Cardiovascular	870.2880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18673	Blood flowmeter catheter, Doppler	A device that is a flexible tube designed for insertion within the blood vessels for the purpose of determining blood-flow velocity by measuring the ultrasonic frequency shift between the transmitted and reflected signals (Doppler principle). It typically has a ceramic crystal attached at or near its distal tip that is capable of both transmitting and receiving ultrasound signals [20 megahertz (MHz) frequency is typical]. The proximal end is connected to a Doppler blood flowmeter unit where the measurements are displayed. It is typically used for measurement of the coronary haemodynamics (e.g., blood mean and peak velocity) during coronary procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002213630	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place. Temperature limits to which the medical device can be safely exposed is -40 to +60 degrees Celsius. Humidity limitation - Non-condensing environment.