Pulsewave Blood Pressure Monitor

GUDID 00867661000318

CLOUD DX INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00867661000318
• NIH Device Record Key: b58438c3-2a45-46f3-9753-6a48a88f902f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulsewave Blood Pressure Monitor
• Version Model Number: PAD-1A
• Company DUNS: 079659378
• Company Name: CLOUD DX INC.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 888-543-0944
• Email: regulatory@clouddx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867661000318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122443

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2019-11-08
• Device Publish Date: 2019-09-18

Devices Manufactured by CLOUD DX INC.

• 00867661000370 - Wireless Infrared Thermometer: 2022-05-18
• 00867661000356 - Wireless Pulse Oximeter: 2021-11-10
• 00867661000318 - Pulsewave Blood Pressure Monitor: 2019-11-08
• 00867661000318 - Pulsewave Blood Pressure Monitor: 2019-11-08
• 00867661000349 - Wireless Pulse Oximeter: 2019-09-26