FDA.reportPublic FDA data

WRO 300

Primary DI
00817492020825
Brand
WRO 300
Company
MAR COR PURIFICATION, INC.
Model
RO,WRO 300,115V~,60HZ
Published
2016-09-23
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
FIPSubsystem, Water Purification

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIPSubsystem, Water PurificationGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817492020825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817492020825008174920208258174920208250817492020825

GMDN Terms#

Term, Definition table
TermDefinition
Reverse-osmosis water purification systemAn assembly of devices designed to remove unwanted contaminants (bacteria, viruses, chemicals, dissolved substances) from water using osmotic pressure applied to one side of a selective membrane. The system removes ions, large molecules (e.g. proteins, glucose, urea, salts) and other particles from solution by forcing water at high pressure through a membrane containing pores just big enough (e.g., 0.0005 microns) to permit passage of small molecules and water, whilst the contaminants are flushed to waste.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth20.5Inch
Height22.2Inch
Weight63.9Pound
Width8.1Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature32 Degrees Fahrenheit0 Degrees Fahrenheit
Storage Environment Temperature32 Degrees Fahrenheit0 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8006333080info@mcpur.com

Regulatory Flags#

DUNS number
019056181
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817492020979MCB SeriesMCB 205-50 MF BICARB SEMI SYS2016-09-23
00817492020986MCB SeriesMCB 205-100 MF BICARB SEMI SYS2016-09-23
00817492020993MCB SeriesMCB 212-50 BICARB SEMI SYS2016-09-23
00817492021006MCB SeriesMCB 212-100 BICARB SEMI SYS2016-09-23
00817492021013MCB SeriesMCB 202-50 BICARB SNGL SYS2016-09-23
00817492021020MCB SeriesMCB 202-100 BICARB SNGL SYS2016-09-23
00817492021037MCB SeriesMIXER,BICARB,MCB202-50CD,SINGLE,50GAL2016-09-23
00817492021044MCB SeriesMCB 202-100 CD BICARB SNGL SYS2016-09-23
00817492021051PSDS Bicarb SystemsPSDS,BICARB ONLY2016-09-23
00817492021068PSDS Bicarb SystemsPSDS,BICARB ONLY,HD2016-09-23
00817492021075PSDS Bicarb SystemsPSDS,1 ACID,1 BICARB2016-09-23
00817492021082PSDS Bicarb SystemsPSDS,1 ACID,1 BICARB,HD2016-09-23
00817492021099PSDS Bicarb SystemsPSDS,2 ACID,1 BICARB2016-09-23
00817492021105PSDS Bicarb SystemsPSDS,2 ACID,1 BICARB,HD2016-09-23
00817492021112PSDS Bicarb SystemsPSDS,3 ACID,1 BICARB2016-09-23
00817492021129PSDS Bicarb SystemsPSDS,3 ACID,1 BICARB,HD2016-09-23
00817492021136SDS Bicarb SystemsSDS,REMOTE,BICARB ONLY,HD,70G TANK2016-09-23
00817492021143SDS Bicarb SystemsSDS,REMOTE,1 ACID,1 BICARB,HD,70G TANK2016-09-23
00817492021150SDS Bicarb SystemsSDS,REMOTE,2 ACID,1 BICARB,HD,70G TANK2016-09-23
00817492021167SDS Bicarb SystemsSDS,REMOTE,3 ACID,1 BICARB,HD,70G TANK2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817927020345AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020352AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020369AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020376AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020383AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020390AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020406AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020413AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
04039361261313DIASAFE®plusUSFresenius Medical Care AGFIP2026-05-01
00850001011266Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00850001011341Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00850001011358Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00860008016942Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016904Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016911Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016928Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016959Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016966Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
RO0258E-2436RO, 8640GPD, 208V, 4MEMBETTER WATER, LLCFIP2024-11-13
PB0002MEDI-PORT PBII R.O. 220VBETTER WATER, LLCFIP2024-11-13
PB0003MEDI-PORT PBII R.O. 120VBETTER WATER, LLCFIP2024-11-13
PR0023"PRETREAT, 1"", 208V, CPVC, SHORT, AC"BETTER WATER, LLCFIP2024-11-13
PS0155"POST-TREAT, .03 30"", 208V"BETTER WATER, LLCFIP2024-11-13
04251285200524AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200531AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200548AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200555AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200562AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200579AquaB LITEVIVONIC GmbHFIP2024-07-25