Radius-7

GUDID 00843997012997

with Wi-Fi

MASIMO CORPORATION

Pulse Co-oximeter

• Primary Device ID: 00843997012997
• NIH Device Record Key: 0c704317-c5da-4119-915b-667ee60c0435
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radius-7
• Version Model Number: 9837
• Company DUNS: 780421038
• Company Name: MASIMO CORPORATION
• 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(949)297-7498
• Email: TechService-US@masimo.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 540 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997012997 [Primary]

FDA Product Code

• DQA: Oximeter

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: 2019-10-01
• Device Publish Date: 2019-09-23

On-Brand Devices [Radius-7]

• 00843997012997: with Wi-Fi
• 00843997014274: Radius-7 Conversion Kit
• 00843997014267: Radius-7 Wearable Pulse CO-Oximeter
• 00843997014144: Radius-7 with Wi-Fi Conversion Kit
• 00843997014106: Radius-7 Wearable Pulse CO-Oximeter with Wi-Fi
• 00843997009249: Radius-7 Wearable Pulse CO-Oximeter
• 00843997014137: Radius-7 Wearable Instrument
• 00843997014120: Radius-7 with Wi-Fi Wearable Instrument
• 00843997010047: Radius-7 Wearable Instrument