FDA.reportPublic FDA data

RESMED

Primary DI
00619498279357
Brand
RESMED
Company
RESMED PTY LTD
Model
27935
Catalog number
27935
Device description
MEDICAL OXYGEN SENSOR
Published
2016-09-30
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
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082655000ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106Envitec-Wismar GmbH2008-11-25CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00619498279357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498279357006194982793576194982793570619498279357

GMDN Terms#

Term, Definition table
TermDefinition
Portable electric ventilatorA portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
751149311
Device count
1
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
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10889483588673Vital Signs™AirLife Finland OyCCL2025-03-31
10889483588697Vital Signs™AirLife Finland OyCCL2025-03-31
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
00817770025856MaxBlend2MAXTEC, LLCCCL2024-08-14
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCCL2024-05-13
10190752191235Vital Signs™AirLife Finland OyCCL2023-05-30
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCCL2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyCCL2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCCL2023-04-19
00195278524089NAGE Healthcare Finland OyCCL2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyCCL2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyCCL2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyCCL2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682104302NAGE Healthcare Finland OyCCL2022-03-07
10190752111349Vital Signs™Vyaire GmbHCCL2021-04-02
10190752143777Vital Signs™AirLife Finland OyCCL2021-03-05
10190752143784Vital Signs™AirLife Finland OyCCL2021-03-05
10190752143791Vital Signs™AirLife Finland OyCCL2021-03-05
10190752140844Vital Signs™AirLife Finland OyCCL2021-01-28
10190752140912Vital Signs™AirLife Finland OyCCL2021-01-28
10190752141827Vital Signs™AirLife Finland OyCCL2021-01-28