InnoSight Diagnostic Ultrasound System

GUDID 04719873000012

InnoSight Diagnostic Ultrasound System

QISDA CORPORATION

General-purpose ultrasound imaging system

• Primary Device ID: 04719873000012
• NIH Device Record Key: 79350d1b-d977-49b1-8a5d-dfef4936682a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InnoSight Diagnostic Ultrasound System
• Version Model Number: 989605463521
• Company DUNS: 656079068
• Company Name: QISDA 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873000012 [Primary]

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

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: 2018-05-23
• Device Publish Date: 2018-01-08

On-Brand Devices [InnoSight Diagnostic Ultrasound System]

• 04719873000265: InnoSight Diagnostic Ultrasound System
• 04719873000012: InnoSight Diagnostic Ultrasound System
• 04719873000333: InnoSight Diagnostic Ultrasound System
• 04719873000258: InnoSight Diagnostic Ultrasound System
• 04719873000319: InnoSight Diagnostic Ultrasound System
• 04719873000517: InnoSight Diagnostic Ultrasound System