Halo 700-C2701-131

GUDID 04719876420275

Automated Portable Retinal Camera

CRYSTALVUE MEDICAL CORPORATION

Ophthalmic fundus camera

• Primary Device ID: 04719876420275
• NIH Device Record Key: b41781fd-fc35-4d63-918e-7d928b96a0b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halo
• Version Model Number: Halo
• Catalog Number: 700-C2701-131
• Company DUNS: 658841648
• Company Name: CRYSTALVUE MEDICAL 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: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw
• Phone: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw
• Phone: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw
• Phone: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw
• Phone: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw
• Phone: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw
• Phone: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw
• Phone: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw
• Phone: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw
• Phone: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw
• Phone: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw
• Phone: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw
• Phone: +88633607711
• Email: Oliver.Lin@crystalvue.com.tw

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719876420275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210197

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

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: 2021-07-19
• Device Publish Date: 2021-07-10

Devices Manufactured by CRYSTALVUE MEDICAL CORPORATION

• 04719876420398 - Vitazi View™: 2024-05-28 Automated Portable Retinal Camera
• 04719876420268 - NFC-600: 2021-07-19 Automated Portable Retinal Camera
• 04719876420275 - Halo: 2021-07-19Automated Portable Retinal Camera
• 04719876420275 - Halo: 2021-07-19 Automated Portable Retinal Camera
• 04719876420176 - Polaris: 2020-07-28 Non-Mydriatic Auto Fundus Camera
• 04719876420060 - RetinaStation: 2020-07-02 Non-Mydriatic Auto Fundus Camera
• 04719876420053 - NFC-700: 2020-07-02 Non-Mydriatic Auto Fundus Camera