FDA.reportPublic FDA data

AIRTOUCH F40

Primary DI
00619498647002
Brand
AIRTOUCH F40
Company
RESMED PTY LTD
Model
64700
Device description
AIRTOUCH F40 SYS - SW/STD AMER
Published
2026-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
00619498647002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498647002006194986470026194986470020619498647002

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
751149311
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00619498647019AIRTOUCH F40647012026-08-25
00619498647033AIRTOUCH F40647032026-08-25
00619498647040AIRTOUCH F40647042026-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00619498647019AIRTOUCH F40RESMED PTY LTDMDL2026-08-25
00619498647033AIRTOUCH F40RESMED PTY LTDMDL2026-08-25
00619498647040AIRTOUCH F40RESMED PTY LTDMDL2026-08-25
00619498512027AirCurve 11 ST-ARESMED PTY LTDMDL2026-04-21
00619498512034AirCurve 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