FDA.reportPublic FDA data

SimplyGo

Primary DI
00606959028838
Brand
SimplyGo
Company
Respironics, Inc.
Model
SimplyGo, BR
Catalog number
1098834
Device description
SimplyGo, Brazil
Published
2017-01-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAWGenerator, oxygen, portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAWGenerator, Oxygen, PortableAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606959028838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959028838006069590288386069590288380606959028838

GMDN Terms#

Term, Definition table
TermDefinition
Portable oxygen concentratorA portable mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is used in a home, institution, or a vehicle and typically has internal batteries for transportable use.

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

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
00885304034834DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00885304034841DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00885304034858DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00860007698262MOSTPacific Consolidated Industries LLCCAW2026-05-06
06934726614316LongfianLongfian Scitech Co., Ltd.CAW2026-05-04
00810178885756ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885763ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885770ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885787ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885794ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885800ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885817ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885824ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00850083102944Rhythm Healthcare, LLCRhythm Healthcare, LLCCAW2026-04-24
00850083102319Rhythm HealthcareRhythm Healthcare, LLCCAW2026-04-22
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
06933257948488YUWELL Portable Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2026-02-24
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-12-02
06953077101160Oxygen concentratorShenyang Canta Medical Tech.Co.,LtdCAW2025-10-08
M766AS200SW460AryaCAIRE INC.CAW2025-08-13
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-08-06
06933257921856YUWELL Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2024-01-09
10840330700396ProcureTwin Med, LLCCAW2022-11-03
M766AS200SW6AryaCAIRE INC.CAW2022-05-26
00855573007761VOCSNVentec Life Systems, Inc.CAW2022-04-12
00709078014062InLine Water TrapWESTMED, INC.CAW2022-03-31
00850018761178VOCSN Power SupplyVentec Life Systems, Inc.CAW2022-03-23
00850018761130VOCSNVentec Life Systems, Inc.CAW2021-03-03
00850018761048VOCSN Patient Breathing PackageVentec Life Systems, Inc.CAW2020-10-07