QuantaFlo

GUDID 00859433006048

Application

SEMLER SCIENTIFIC, INC.

Limb plethysmograph

• Primary Device ID: 00859433006048
• NIH Device Record Key: 81fb5c90-f4d8-4b8c-8150-6ca6b8b3c37b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuantaFlo
• Version Model Number: 91-0013
• Company DUNS: 968030333
• Company Name: SEMLER SCIENTIFIC, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859433006048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143094

FDA Product Code

• JOM: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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: 2018-07-06
• Device Publish Date: 2016-08-19

On-Brand Devices [QuantaFlo]

• 00859433006123: Software Application
• 00859433006079: USB Sensor, Tracking, Bard
• 00859433006062: USB Sensor, Tracking
• 00859433006048: Application
• 00859433006024: USB Sensor