CASSIE

Primary DI
00860007837036
Brand
CASSIE
Company
Wesper Inc.
Model
0.9.0
Device description
Cassie is a Software as a Medical Device (SaMD) that automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices.Cassie is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders in adults.The Cassie output may be displayed and edited by a qualified healthcare professional. The Cassie output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.
Published
2025-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007837036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007837036008600078370368600078370360860007837036

GMDN Terms#

Term, Definition table
TermDefinition
Sleep disorder interpretive software, professional-onlyAn interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081210033
Device count
1
Kit
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007837029Wesper LabWSWW-RE-K-N-V02-BLO2024-07-30
00860007837012Wesper LabWSWW-RE-K-N-V01-GRD2023-08-31

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Primary DI, Brand, Company table
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