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
00619498647002AIRTOUCH F40647002026-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04036616011983Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-27
04036616011839Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011846Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011860Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011877Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011884Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011891Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011907Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011914Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011921Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011938Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011945Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011952Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011969Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011976Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616013482Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyCCL2026-04-15
10889483588635Vital Signs™AirLife Finland OyCCL2025-04-02
10889483588659Vital Signs™AirLife Finland OyCCL2025-03-31
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