FDA.report

Model 7

Primary DI
B577710000
Brand
Model 7
Company
SNAP DIAGNOSTICS
Model
7-10000
Device description
The SNAP Model 7 is a 6 channel data recorder that records respiratory and oximetry data. A canula houses a pressure sensor that records the respirato
Published
2017-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MNRVentilatory Effort Recorder

Product Code Classifications

CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B577710000PrimaryHIBCC0

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
827445854
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B577910000Model 99-100002026-02-10
B577810000Model 88-100002017-08-18

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