FDA.reportPublic FDA data

BioPure HX2

Primary DI
00817492022522
Brand
BioPure HX2
Company
MAR COR PURIFICATION, INC.
Model
HX2P-11812XX
Device description
RO/BIOPURE HX2P-11GPM/460V/3PH/60HZ/DL
Published
2021-02-18
Public version status
New
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
00817492022522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817492022522008174920225228174920225220817492022522

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth37Inch
Height82Inch
Weight3234Pound
Width166Inch

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
8002685035orderdesk@mcpur.com

Regulatory Flags#

DUNS number
019056181
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817492021297NAGENERATOR,O3Z,2.3GM/H2016-09-23
00817492021815NAGENERATOR,O3Z-E,0-4GM/HRNA2017-04-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860013284114Mixed Bed DI tankBTI FiltrationFIP2026-10-27
00860013284121Mixed Bed DI tankBTI FiltrationFIP2026-10-27
00860013284138Mixed Bed DI tankBTI FiltrationFIP2026-10-27
00860013284145Carbon TankBTI FiltrationFIP2026-10-27
00860013284152Carbon TankBTI FiltrationFIP2026-10-27
00860013284169Carbon TankBTI FiltrationFIP2026-10-27
00860013284176Carbon TankBTI FiltrationFIP2026-10-27
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