Athelas

GUDID 00860001013290

Blood Pressure Monitor

Athelas, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00860001013290
• NIH Device Record Key: ab35f58a-1873-48fe-8712-d0e173af4ac5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Athelas
• Version Model Number: AthelasBP01
• Company DUNS: 080636378
• Company Name: Athelas, 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001013290 [Primary]

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: 2021-10-08
• Device Publish Date: 2021-09-30

Devices Manufactured by Athelas, Inc.

• 00860008385840 - Athelas Home: 2022-08-08
• 00860008385864 - Athelas Home: 2022-08-08
• 00860001013290 - Athelas: 2021-10-08Blood Pressure Monitor
• 00860001013290 - Athelas: 2021-10-08 Blood Pressure Monitor
• 00860001013238 - Athelas One: 2019-12-23
• 00860001013221 - Athelas One: 2019-04-11