Sunrise

Basic Information

• Brand Name: Sunrise
• Primary DI: 05430001896084
• Version / Model: 2
• Catalog Number: A500
• Company Name: Sunrise
• Labeler DUNS: 370979169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-30
• Public Version: 2
• Public Version Date: 2023-06-30
• Public Version Status: Update
• Public Device Record Key: a7b95bff-3205-4a00-afbd-60a1882c18a5

Device Description

Sunrise sensor 2 (multi-nights)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QRS	Device For Sleep Apnea Testing Based On Mandibular Movement	Ear, Nose, Throat	868.2376	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62230	Home-use sleep apnoea recording system	A battery-powered device assembly intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort/pattern, airflow waveform) during sleep in the home, to facilitate the diagnosis of sleep apnoea [e.g., obstructive sleep apnoea (OSA)]. It includes primary components such as sensors (e.g., air pressure sensor) and/or a control unit which may have some user-interface functionality, and typically additional devices which may include a gas sampling face mask and/or connecting leads/cables; collected data is transferred to a central database or computerized device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05430001896084	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K222262	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 27 Degrees Celsius