FDA.reportPublic FDA data

BIPAP autoSV Advanced System One 60 Series

Primary DI
00606959038028
Brand
BIPAP autoSV Advanced System One 60 Series
Company
Respironics, Inc.
Model
BiPAP autoSV Advanced, 60 Series, 30cm, DE
Catalog number
962T
Device description
BiPAP autoSV Advanced 60 Series 30cm, Germany
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00606959038028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959038028006069590380286069590380280606959038028

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
Serial number
true

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
08401934313389ResScanRESMED CORP.MNS2023-02-24
08401934313396ResScanRESMED CORP.MNS2023-02-24
00606959049024DreamMapper Web (DM)Respironics, Inc.MNS2020-10-16
00606959049031DreamMapper Web (EMEA)Respironics, Inc.MNS2020-10-16
00606959049048DreamMapper Web (APAC)Respironics, Inc.MNS2020-10-16
00606959049055DreamMapper Mobile App Android (DMM)Respironics, Inc.MNS2020-10-16
00606959049086DreamMapper App iOSRespironics, Inc.MNS2020-10-16
00606959049093DreamMapper App iOS (EMEA)Respironics, Inc.MNS2020-10-16
00606959049840Care OrchestratorRespironics, Inc.MNS2020-10-16
00606959049109DreamMapper App iOS (APAC)Respironics, Inc.MNS2020-10-07
00606959044203Care OrchestratorRespironics, Inc.MNS2020-09-23
00606959052093DreamMapper Web (DM)Respironics, Inc.MNS2020-05-20
00606959053519DreamMapper Web (EMEA)Respironics, Inc.MNS2020-05-20
00606959033344Li Ion Battery, Ventilation, JapanRespironics, Inc.MNS2019-06-05
00606959049871DreamMapper Web (APAC)Respironics, Inc.MNS2019-04-19
00606959049925DreamMapper Android China Instance v 2.11Respironics, Inc.MNS2019-04-19
00606959049888DreamMapper Web China Instance v 2.11Respironics, Inc.MNS2019-04-18
00606959049895DreamMapper Mobile App Android (DMM)Respironics, Inc.MNS2019-04-18
00606959049901DreamMapper Mobile App Android (EMEA)Respironics, Inc.MNS2019-04-18
00606959049918DreamMapper Mobile App Android (APAC)Respironics, Inc.MNS2019-04-18
00606959033306BatteryRespironics, Inc.MNS2019-03-04
00606959054820EncoreAnywhereRespironics, Inc.MNS2019-01-14
00606959054837EncoreAnywhereRespironics, Inc.MNS2019-01-14
00606959053984Care Orchestrator EssenceRespironics, Inc.MNS2018-12-20
00606959054790Care OrchestratorRespironics, Inc.MNS2018-12-10
00606959054189DreamMapperRespironics, Inc.MNS2018-10-30
00606959054196DreamMapperRespironics, Inc.MNS2018-10-30
00606959054202DreamMapperRespironics, Inc.MNS2018-10-30
00606959054219DreamMapperRespironics, Inc.MNS2018-10-30
00606959054226DreamMapperRespironics, Inc.MNS2018-10-30