Sunrise

Primary DI
05430001896060
Brand
Sunrise
Company
Sunrise
Model
1
Device description
Sunrise sensor
Published
2022-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QRSDevice For Sleep Apnea Testing Based On Mandibular Movement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRSDevice For Sleep Apnea Testing Based On Mandibular MovementEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN210015000
K222262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN210015000Sunrise Sleep Disorder Diagnostic AidSunrise2022-01-07QRS
K222262000SunriseSunrise SA2022-12-22QRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430001896060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430001896060054300018960605430001896060

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3281261126support@hellosunrise.com

Regulatory Flags#

DUNS number
370979169
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05430001896084Sunrise2A5002023-01-30
05430001896091Sunrise2A6002023-01-30
05430001896015Sunrise12022-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05430001896084SunriseSunriseQRS2023-01-30
05430001896091SunriseSunriseQRS2023-01-30
05430001896015SunriseSunriseQRS2022-06-30