Hokanson

Basic Information

• Brand Name: Hokanson
• Primary DI: 00817065021396
• Version / Model: RT2000
• Catalog Number: 00334
• Company Name: D.E.HOKANSON, INC.
• Labeler DUNS: 071829634
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2020-10-05
• Public Version Status: Update
• Public Device Record Key: b5f0b38a-0bb6-4ec1-a521-6cc0ece3e97f

Device Description

ECG TRIGGER - A battery powered instrument used to acquire an ECG signal from a subject. The instrument filters and amplifies the patient's ECG R-wave, then sends the signal to a parent device via and optically isolated interface cable. The output signal can be used by the parent device to synchronize another event with the subject’s R-Wave. The waveform is NOT used for analysis or diagnosis due to the ECG signal filtering.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: 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
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	870.2780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62332	Electrocardiographic modulated activator	A hand-held, battery-powered device intended to gather electrocardiographic (ECG) data for real-time control (activation) of a separate device (e.g., a regulator during rapid vascular cuff inflation) at a specific point during the patient’s cardiac cycle. It a small electronic unit with ECG leads intended to be used as part of noninvasive patient diagnosis; it is not designed to gather ECG data for analysis/diagnosis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817065021396	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023707	000