Actiwave 08-536

GUDID B329AWV02M25

Ambulatory Electromyogram (EMG) - two channel

CAMNTECH LIMITED

Telemetric electrocardiographic ambulatory recorder

• Primary Device ID: B329AWV02M25
• NIH Device Record Key: 9ba7d8f7-daee-4ee4-a542-a3d6658d8978
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Actiwave
• Version Model Number: 2M
• Catalog Number: 08-536
• Company DUNS: 399114941
• Company Name: CAMNTECH LIMITED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 830-755-8036
• Email: sales@camntech.com
• Phone: +1 830-755-8036
• Email: sales@camntech.com
• Phone: +1 830-755-8036
• Email: sales@camntech.com
• Phone: +1 830-755-8036
• Email: sales@camntech.com
• Phone: +1 830-755-8036
• Email: sales@camntech.com
• Phone: +1 830-755-8036
• Email: sales@camntech.com
• Phone: +1 830-755-8036
• Email: sales@camntech.com
• Phone: +1 830-755-8036
• Email: sales@camntech.com
• Phone: +1 830-755-8036
• Email: sales@camntech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B329AWV02M25 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100266

FDA Product Code

• MWJ: Electrocardiograph,Ambulatory(Without Analysis)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-24

On-Brand Devices [Actiwave]

• B329AWVM33: Ambulatory Accelerometry recorder - triaxial
• B329AWVC23: Ambulatory ECG recorder with accelerometer - single channel
• B329AWV04E22: Ambulatory ECG/EEG recorder - four channel
• B329AWV02M25: Ambulatory Electromyogram (EMG) - two channel
• B329AWV02E25: Ambulatory ECG/EEG recorder - two channel
• B329AWV01E22: Ambulatory ECG/EEG recorder - single channel