Actiheart 08-305

GUDID B329AH420

Ambulatory ECG recorder with acclerometer - single channel

CAMNTECH LIMITED

Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder

• Primary Device ID: B329AH420
• NIH Device Record Key: 96e75109-6645-4035-ba26-c2651f598f6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Actiheart
• Version Model Number: AH4
• Catalog Number: 08-305
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B329AH420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052489

FDA Product Code

• GWK: Conditioner, Signal, Physiological

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 [Actiheart]

• B329AH420: Ambulatory ECG recorder with acclerometer - single channel
• B329AHBT56: Ambulatory ECG recorder with acclerometer - single channel
• B329AH556: Ambulatory ECG recorder with acclerometer - single channel