FDA.reportPublic FDA data

AIRCURVE

Primary DI
00619498282241
Brand
AIRCURVE
Company
RESMED PTY LTD
Model
28224
Catalog number
28224
Device description
AIRCURVE 10 ST-A IVAPS
Published
2020-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNSVentilator, Continuous, Non-Life-Supporting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00619498283316Direct MarkingGS10
00619498282241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498283316006194982833166194982833160619498283316
00619498282241006194982822416194982822410619498282241

GMDN Terms#

Term, Definition table
TermDefinition
Home BPAP unitA portable mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using bi-level positive airway pressure (BPAP) during spontaneous respiration for adult/child (non-infant) patients affected by obstructive sleep apnoea (OSA) and/or to treat patients with conditions requiring respiratory assistance in the home [e.g., chronic obstructive pulmonary disease (COPD)]. It is a small desktop unit with controls, and may include a built-in humidifier. The device is intended for use in the home but may also be used in healthcare facilities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00619498279173Astral27917279172015-12-04
00619498279494Astral27949279492016-02-26
00619498279791Astral Slimbag Bed Support27979279792018-07-23
00619498512027AirCurve 11 ST-A512022026-04-21
00619498512034AirCurve 11 ST-A512032026-04-21
00619498512157AirCurve 11 ST-A512152026-04-21
00619498374717HumidAir37471374712026-02-09
00619498004409HumidAir37471374712026-02-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08401934313389ResScanRESMED CORP.MNS2023-02-24
08401934313396ResScanRESMED CORP.MNS2023-02-24
00606959049024DreamMapper Web (DM)Respironics, Inc.MNS2020-10-16
00606959049031DreamMapper Web (EMEA)Respironics, Inc.MNS2020-10-16
00606959049048DreamMapper Web (APAC)Respironics, Inc.MNS2020-10-16
00606959049055DreamMapper Mobile App Android (DMM)Respironics, Inc.MNS2020-10-16
00606959049086DreamMapper App iOSRespironics, Inc.MNS2020-10-16
00606959049093DreamMapper App iOS (EMEA)Respironics, Inc.MNS2020-10-16
00606959049840Care OrchestratorRespironics, Inc.MNS2020-10-16
00606959049109DreamMapper App iOS (APAC)Respironics, Inc.MNS2020-10-07
00606959044203Care OrchestratorRespironics, Inc.MNS2020-09-23
00606959052093DreamMapper Web (DM)Respironics, Inc.MNS2020-05-20
00606959053519DreamMapper Web (EMEA)Respironics, Inc.MNS2020-05-20
00606959033344Li Ion Battery, Ventilation, JapanRespironics, Inc.MNS2019-06-05
00606959049871DreamMapper Web (APAC)Respironics, Inc.MNS2019-04-19
00606959049925DreamMapper Android China Instance v 2.11Respironics, Inc.MNS2019-04-19
00606959049888DreamMapper Web China Instance v 2.11Respironics, Inc.MNS2019-04-18
00606959049895DreamMapper Mobile App Android (DMM)Respironics, Inc.MNS2019-04-18
00606959049901DreamMapper Mobile App Android (EMEA)Respironics, Inc.MNS2019-04-18
00606959049918DreamMapper Mobile App Android (APAC)Respironics, Inc.MNS2019-04-18
00606959033306BatteryRespironics, Inc.MNS2019-03-04
00606959054820EncoreAnywhereRespironics, Inc.MNS2019-01-14
00606959054837EncoreAnywhereRespironics, Inc.MNS2019-01-14
00606959053984Care Orchestrator EssenceRespironics, Inc.MNS2018-12-20
00606959054790Care OrchestratorRespironics, Inc.MNS2018-12-10
00606959054189DreamMapperRespironics, Inc.MNS2018-10-30
00606959054196DreamMapperRespironics, Inc.MNS2018-10-30
00606959054202DreamMapperRespironics, Inc.MNS2018-10-30
00606959054219DreamMapperRespironics, Inc.MNS2018-10-30
00606959054226DreamMapperRespironics, Inc.MNS2018-10-30