FDA.reportPublic FDA data

SIMPLYFLO,NORTH AMERICA

Primary DI
00606959028845
Brand
SIMPLYFLO,NORTH AMERICA
Company
Respironics, Inc.
Model
00
Catalog number
1076773
Device description
SimplyFLO, North America
Published
2016-09-23
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
CAWGenerator, oxygen, portable

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606959028845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959028845006069590288456069590288450606959028845

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
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 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
10810178884459ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00810178884469ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00810178885190ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00092237627495Roscoe MedicalCOMPASS HEALTH BRANDS CORP.CAW2026-01-15
06971882890314Rhythm HealthcareQingdao Kingon Medical Science and Technology Co., LtdCAW2026-01-07
06971882891328Rhythm HealthcareQingdao Kingon Medical Science and Technology Co., LtdCAW2026-01-07
06934726614347LongfianLongfian Scitech Co., Ltd.CAW2025-12-10
06934726614446Phoenix Pulse POCLongfian Scitech Co., Ltd.CAW2025-12-09
06972855530329Portable Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co.,LtdCAW2025-11-28
00860014866548Rhythm Healthcare, LLCRhythm Healthcare, LLCCAW2025-11-12
06977388230012WeOxyWeoxy Co., LTD.CAW2025-09-25
06977388230029WeOxyWeoxy Co., LTD.CAW2025-09-25
06977388230036WeOxyWeoxy Co., LTD.CAW2025-09-25
06978651650070RHYTHM HEALTHCARERhythm Healthcare, LLCCAW2025-09-01
M766AS2001410CAIRE Inc.CAIRE INC.CAW2025-08-13
M766AS2001460AryaCAIRE INC.CAW2025-08-13
M766AS2002410CAIRE Inc.CAIRE INC.CAW2025-08-13
M766AS2002460AryaCAIRE INC.CAW2025-08-13
M766AS200410CAIRE Inc.CAIRE INC.CAW2025-08-13
M766AS200460AryaCAIRE INC.CAW2025-08-13
M766AS200SW410CAIRE Inc.CAIRE INC.CAW2025-08-13
M766SCE1000NANB0HOMESTYLE AspenCAIRE INC.CAW2025-06-30
00817131020698OxyGo Fit+ Rove 4 Inogen, Inc.CAW2025-06-12
00817131020704Oxygo Next Rove 6 Inogen, Inc.CAW2025-06-11
06933257935419InogenJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2025-06-11
06933257924925YUWELL Portable Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2025-06-10
00840117342736Resp-O2 10L Oxygen Concentrator Dynarex CorporationCAW2025-06-03
00817698020698Healthcare Logistics SystemsHEALTHCARE LOGISTICS SYSTEMS LLCCAW2025-05-01
00885304033219DeVilbissDEVILBISS HEALTHCARE LLCCAW2025-04-28
00885304033226DeVilbissDEVILBISS HEALTHCARE LLCCAW2025-04-28