Sunrise

GUDID 05430001896015

Sunrise software

Sunrise

Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only Sleep disorder interpretive software, professional-only

• Primary Device ID: 05430001896015
• NIH Device Record Key: 42cca10b-bc06-45e4-bad4-3a5f842a6975
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunrise
• Version Model Number: 1
• Company DUNS: 370979169
• Company Name: Sunrise
• 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: false
• 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

Customer Support Contacts

• Phone: +3281261126
• Email: support@hellosunrise.com
• Phone: +3281261126
• Email: support@hellosunrise.com
• Phone: +3281261126
• Email: support@hellosunrise.com
• Phone: +3281261126
• Email: support@hellosunrise.com
• Phone: +3281261126
• Email: support@hellosunrise.com
• Phone: +3281261126
• Email: support@hellosunrise.com
• Phone: +3281261126
• Email: support@hellosunrise.com
• Phone: +3281261126
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com
• Phone: 9999999999
• Email: support@hellosunrise.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430001896015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN210015

FDA Product Code

• QRS: Device For Sleep Apnea Testing Based On Mandibular Movement

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: 2022-07-08
• Device Publish Date: 2022-06-30

On-Brand Devices [Sunrise]

• 05430001896060: Sunrise sensor
• 05430001896015: Sunrise software
• 05430001896091: Sunrise sensor 2 (single night)
• 05430001896084: Sunrise sensor 2 (multi-nights)