PRO-Diary 05-121

GUDID B329PDV25

Ambulatory Physical Activity Recorder with Electronic Patient diary

CAMNTECH LIMITED

Kinesiology ambulatory recorder

• Primary Device ID: B329PDV25
• NIH Device Record Key: 241ff69c-ff87-4639-9328-042770dea041
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRO-Diary
• Version Model Number: PDV
• Catalog Number: 05-121
• Company DUNS: 399114941
• Company Name: CAMNTECH LIMITED
• Device Count: 1
• DM Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B329PDV25 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132764

FDA Product Code

• LEL: Device, Sleep Assessment

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-08-29

On-Brand Devices [PRO-Diary]

• B329PDM25: Ambulatory Physical Activity Recorder with Electronic Patient diary
• B329PDV25: Ambulatory Physical Activity Recorder with Electronic Patient diary