Blipcare

GUDID 10858393004009

Wireless Blood Pressure Monitor

CAREMATIX, INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10858393004009
• NIH Device Record Key: 1e251ce9-aa06-46a2-88ff-98d285b040a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blipcare
• Version Model Number: BP-700WF
• Company DUNS: 018835467
• Company Name: CAREMATIX, 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: +13126279300
• Email: support@blipcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858393004002 [Primary]
GS1	10858393004009 [Package]; Contains: 00858393004002; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123020

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: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-11-30

On-Brand Devices [Blipcare]

• 10858393004009: Wireless Blood Pressure Monitor
• 00858393004033: Cellular Blood Pressure Monitor