FDA.reportPublic FDA data

DreamStation

Primary DI
00606959040861
Brand
DreamStation
Company
Respironics, Inc.
Model
00
Catalog number
PPX900S10
Device description
DreamStation BiPAP autoSV, Postponement
Published
2016-11-01
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
MNSVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606959040861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959040861006069590408616069590408610606959040861

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)744-2500respironics.service@philips.com

Regulatory Flags#

DUNS number
080728314
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606959055735Sleepware G3 Sleepware G3 2026-01-22
00606959060586Care OrchestratorCare Orchestrator2026-01-22
00606959424852DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H tube w/Cell,AUX900T15C2017-02-01
00606959424944DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell,AUX1131H15C2017-02-10
00606959424951DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Cell, AUAUX1131S15C2017-02-10
00606959424968DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/CeAUX1131T15C2017-02-10
00606959424975DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi,AUX1131H15W2017-02-10
00606959424982DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/WiFi, AUAUX1131S15W2017-02-10
00606959424999DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WAUX1131T15W2017-02-10
00606959425378DreamStation01CNX1130T172019-12-29
00606959425385DreamStation01CNX1131H172019-12-29
00606959425392DreamStation01CNX1131S172019-12-29
00606959425408DreamStation01CNX1131T172019-11-20
00606959425484DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/CellCAX900T12C2017-02-01
00606959425491DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/WiFiCAX900T12W2017-02-01
00606959425538DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/Cell, CACAX1130H12C2017-02-10
00606959425545DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Cell, CACAX1130S12C2017-02-10
00606959425552DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humid w/H Tube w/CellCAX1130T12C2017-02-10
00606959425569DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CACAX1130H12W2017-02-10
00606959425576DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/WiFi, CACAX1130S12W2017-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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