FDA.reportPublic FDA data

REMOTE ALARM

Primary DI
00619498279036
Brand
REMOTE ALARM
Company
RESMED LIMITED
Model
27903
Catalog number
27903
Device description
REMOTE ALARM II
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNTVentilator, Continuous, Minimal Ventilatory Support,Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNTSv70 VentilatorAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00619498279036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498279036006194982790366194982790360619498279036

GMDN Terms#

Term, Definition table
TermDefinition
Airway pressure alarmA battery-powered warning device that monitors a patient's upper airway pressure during assisted mechanical ventilation; it typically being connected to the breathing circuit. In the event of either the pressure not rising above a minimum threshold within a maximum time span or exceeding a pre-set maximum level, the device will signal a warning.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00619498390014AIR 1139001390012021-06-25
00619498390021AIR 1139002390022021-06-25
00619498390038AIR 1139003390032021-06-25
00619498390045AIR 1139004390042021-06-25
00619498390052AIR 1139005390052021-06-25
00619498393022AIR 1139302393022021-06-25
00619498393039AIR 1139303393032021-06-25
00619498393046AIR 1139304393042021-06-25
00619498393053AIR 1139305393052021-06-25
00619498393060AIR 1139306393062021-06-25
00619498393077AIR 1139307393072021-06-25
00619498629442AirFit P1062944629442021-05-06
00619498629459AirFit P1062945629452021-05-06
00619498394203AIR 1139300393002021-03-31
00619498391004HUMIDAIR11 STANDARD39100391002021-03-31
00619498003273CLIMATELINEAIR 1139102391022021-03-31
00619498392056AIR 1139205392052021-03-31
00619498392209AIR 1139220392202021-03-31
00619498393008AIR 1139300393002021-03-31
00619498393015AIR 1139301393012021-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012465528Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2025-08-13
09420012480873Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2025-08-13
07321820070145Vivo 1/2, Vivo 3Breas Medical ABMNT2025-05-20
07321820072026Vivo 1/2, Vivo 3Breas Medical ABMNT2025-05-20
07321820073801Vivo 1/2, Vivo 3Breas Medical ABMNT2025-05-20
07321820070794Vivo 1/2, Vivo 3Breas Medical ABMNT2025-05-19
07321822290008Vivo 3Breas Medical ABMNT2025-05-19
09420012466679Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2024-09-11
07325710015117Servo-air LiteMaquet Critical Care ABMNT2023-09-21
10843685100057Nihon Kohden NIHON KOHDEN ORANGEMED, INC.MNT2022-10-11
10843685100064Nihon Kohden NIHON KOHDEN ORANGEMED, INC.MNT2022-10-11
20843685100078Nihon Kohden NIHON KOHDEN ORANGEMED, INC.MNT2022-10-11
00843685100135Nihon KohdenNIHON KOHDEN ORANGEMED, INC.MNT2022-10-11
10843685100170Nihon Kohden NIHON KOHDEN ORANGEMED, INC.MNT2022-10-11
09420012455710Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012454973Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455345Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455734Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012459701Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460301Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460622Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460646Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460745Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460769Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460783Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460806Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
00843685100043Nihon KohdenNIHON KOHDEN ORANGEMED, INC.MNT2022-07-18
00606959054165BiPAPRespironics, Inc.MNT2021-05-28
00606959059443BiPAPRespironics, Inc.MNT2021-03-19
00606959059450BiPAP A40 EFL, ARRespironics, Inc.MNT2021-03-19