Halo 700-C2701-131

GUDID 04719876420275

Automated Portable Retinal Camera

CRYSTALVUE MEDICAL CORPORATION

Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera 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

• 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