Veridian Healthcare

GUDID 10845717011027

SmartHeart Wrist Blood Pressure Monitor

VERIDIAN HEALTHCARE LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10845717011027
• NIH Device Record Key: 72ac239f-ed99-4726-839c-512dd0858142
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Veridian Healthcare
• Version Model Number: 01-574
• Company DUNS: 830437997
• Company Name: VERIDIAN HEALTHCARE LLC
• 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: true
• Serial Number: false
• 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: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com
• Phone: 8663261313
• Email: info@veridianhealthcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845717011020 [Primary]
GS1	10845717011027 [Package]; Contains: 00845717011020; Package: MASTER CARTON [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213503

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-18
• Device Publish Date: 2024-09-10

On-Brand Devices [Veridian Healthcare]

• 00845717008624: TENS REPLACEMENT ELECTRODE PADS FOR 22-043 (1) EACH LARGE AND SMALL
• 00845717007948: TENS unit with heat and conductive back wrap
• 00845717007931: TENS unit with heat and conductive heating knee wrap
• 00845717007924: Conductive Heating Belt for model 22-033 TENS unit
• 00845717007917: Conductive Heating Knee Wrap for model 22-033 TENS unit
• 00845717007863: BUTTERFLY AND LARGE OVAL REPLACEMENT ELECTRODES
• 00845717007313: WIRED TENS REPLACEMENT ELECTRODES
• 00845717007290: WIRED TENS UNIT
• 10845717000236: Heritage Latex-Free Aneroid Sphygmomanometer, Child
• 00845717000222: Heritage Latex-Free Aneroid Sphygmomanometer, Large Adult
• 00845717000215: Heritage Series Aneroid Sphygmomanometer
• 10845717011027: SmartHeart Wrist Blood Pressure Monitor
• 10845717011010: SmartHeart Arm Blood Pressure Monitor