Sunrise A500

GUDID 05430001896084

Sunrise sensor 2 (multi-nights)

Sunrise

Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system

• Primary Device ID: 05430001896084
• NIH Device Record Key: a7b95bff-3205-4a00-afbd-60a1882c18a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunrise
• Version Model Number: 2
• Catalog Number: A500
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430001896084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222262

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-30
• Device Publish Date: 2023-01-30

On-Brand Devices [Sunrise]

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