FDA.report

VPAP Tx

Primary DI
00619498360482
Brand
VPAP Tx
Company
RESMED LIMITED
Model
36048
Device description
VPAP Tx Americas
Published
2017-01-30
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

Related Records

Contact Domains

Product Codes

CodeName
MNSVentilator, Continuous, Non-Life-Supporting

Product Code Classifications

CodeDeviceSpecialtyClass
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00619498360482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00619498360482006194983604826194983604820619498360482

GMDN Terms

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).

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius80 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-427-0737reception@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
false
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 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 DIBrandCompanyProduct codePublished
07321820070060Vivo 1/2, Vivo 3Breas Medical ABMNS2025-05-20
07321820072033Vivo 1/2, Vivo 3Breas Medical ABMNS2025-05-20
07321820069903Vivo 1/2, Vivo 3Breas Medical ABMNS2025-05-19
07321820070008Vivo 1/2, Vivo 3Breas Medical ABMNS2025-05-19
07321822270000Vivo 1/2Breas Medical ABMNS2025-05-19
07321822280009Vivo 1/2Breas Medical ABMNS2025-05-19
00840193400276AirViewRESMED CORP.MNS2024-10-02
10850001175026ReddyPortSMD Manufacturing LLCMNS2024-01-16
10850001175064ReddyPortSMD Manufacturing LLCMNS2024-01-16
10850001175071ReddyPortSMD Manufacturing LLCMNS2024-01-16
00619498282852AIRCURVERESMED PTY LTDMNS2022-06-10
00840193400108AirViewRESMED CORP.MNS2021-11-30
10850001175002ReddyPortSMD Manufacturing LLCMNS2020-10-28
00606959428607DreamStation ST30Respironics, Inc.MNS2020-10-16
00606959048720A Series, Sys One, Heater HumRespironics, Inc.MNS2020-10-16
00606959048744BiPAP A30Respironics, Inc.MNS2020-10-16
00606959048751BiPAP A30Respironics, Inc.MNS2020-10-16
00606959048768BiPAP A30Respironics, Inc.MNS2020-10-16
00606959049062DreamMapper Mobile App Android (EMEA)Respironics, Inc.MNS2020-10-16
00606959049079DreamMapper Mobile App Android (APAC)Respironics, Inc.MNS2020-10-16
00606959049413BiPAP ST C Series Argentina, 30Respironics, Inc.MNS2020-10-16
00606959050938DreamStation ST30Respironics, Inc.MNS2020-10-16
00606959051362DreamMapper iOS China InstanceRespironics, Inc.MNS2020-10-16
00606959054691BiPAP V30 AutoRespironics, Inc.MNS2020-10-15
00606959061958A Series HumidifierRespironics, Inc.MNS2020-10-15
00606959424524DreamStationRespironics, Inc.MNS2020-09-23
00606959424869DreamStationRespironics, Inc.MNS2020-09-23
00606959424883DreamStationRespironics, Inc.MNS2020-09-23
00606959040601DreamStationRespironics, Inc.MNS2020-09-23
00606959040625DreamStationRespironics, Inc.MNS2020-09-23