Sunrise

Primary DI
05430001896084
Brand
Sunrise
Company
Sunrise
Model
2
Catalog number
A500
Device description
Sunrise sensor 2 (multi-nights)
Published
2023-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K222262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222262000SunriseSunrise SA2022-12-22QRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430001896084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430001896084054300018960845430001896084

GMDN Terms#

Term, Definition table
TermDefinition
Home-use sleep apnoea recording systemA 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.

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
9999999999support@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
05430001896091Sunrise2A6002023-01-30
05430001896015Sunrise12022-06-30
05430001896060Sunrise12022-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05430001896091SunriseSunriseQRS2023-01-30
05430001896015SunriseSunriseQRS2022-06-30
05430001896060SunriseSunriseQRS2022-06-30