FDA.reportPublic FDA data

AirCurve 11 ST-A

Primary DI
00619498512034
Brand
AirCurve 11 ST-A
Company
RESMED PTY LTD
Model
51203
Device description
AirCurve 11 ST-A USA TRI
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MDLImplant, Transmandibular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDLImplant, TransmandibularDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00619498515011Direct MarkingGS10
00619498512034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498515011006194985150116194985150110619498515011
00619498512034006194985120346194985120340619498512034

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
Storage Environment Atmospheric Pressure74 KiloPascal101 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

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
00619498279791Astral Slimbag Bed Support27979279792018-07-23
00619498512027AirCurve 11 ST-A512022026-04-21
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
00619498624423AirTouch F30i624422025-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00619498512027AirCurve 11 ST-ARESMED PTY LTDMDL2026-04-21
00619498512157AirCurve 11 ST-ARESMED PTY LTDMDL2026-04-21
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyMDL2023-04-19
10884521069084ArgyleCardinal Health, Inc.MDL2017-05-25
06945936702977NewsoundXiamen New Sound Technology Co., Ltd.MDL2016-09-01
06945936702984NewsoundXiamen New Sound Technology Co., Ltd.MDL2016-09-01