FDA.reportPublic FDA data

APNEALINK

Primary DI
00619498223541
Brand
APNEALINK
Company
RESMED PTY LTD
Model
22354
Catalog number
22354
Device description
ApneaLink Air Complete Set - US
Published
2016-09-13
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
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00619498223534Direct MarkingGS10
00619498223541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498223534006194982235346194982235340619498223534
00619498223541006194982235416194982235410619498223541

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 Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-424-0737reception@resmed.com

Regulatory Flags#

DUNS number
751149311
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00619498279173Astral27917279172015-12-04
00619498279494Astral27949279492016-02-26
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00619498512157AirCurve 11 ST-A512152026-04-21
00619498374717HumidAir37471374712026-02-09
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00619498624003AirTouch F30i624002025-10-09
00619498624010AirTouch F30i624012025-10-09
00619498624041AirTouch F30i624042025-10-09
00619498624058AirTouch F30i624052025-10-09
00619498624065AirTouch F30i624062025-10-09
00619498624072AirTouch F30i624072025-10-09
00619498624089AirTouch F30i624082025-10-09
00619498624225AirTouch F30i624222025-10-09
00619498624232AirTouch F30i624232025-10-09
00619498624249AirTouch F30i624242025-10-09
00619498624256AirTouch F30i624252025-10-09
00619498624263AirTouch F30i624262025-10-09

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Primary DI, Brand, Company table
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