FDA.reportPublic FDA data

BioPure HX2

Primary DI
00817492021822
Brand
BioPure HX2
Company
Biolab Equipment Ltd
Model
HX2P-05611XX
Published
2017-06-12
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
FIPSubsystem, Water Purification

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133149000BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEMMar Cor Purification, Inc.2014-04-30FIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817492021822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817492021822008174920218228174920218220817492021822

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
Depth37Inch
Height82Inch
Weight2504Pound
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
243149549
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817492021693BioPure HX2HX2P-0561XXX2016-09-23
00817492021327BioPure Portable RO2612A2RO2016-09-23
00817492021334BioPure 4400 RO22M16B2E2016-09-23
00817492021341BioPure 4400 RO22M16B2F2016-09-23
00817492021358BioPure 4400 RO25M16B2E2016-09-23
00817492021365BioPure 4400 RO25M16B2F2016-09-23
00817492021372BioPure 4400 RO32M16B2E 2016-09-23
00817492021389BioPure 4400 RO32M16B2F2016-09-23
00817492021396BioPure 4400 RO35M16B2E2016-09-23
00817492021402BioPure 4400 RO35M16B2F2016-09-23
00817492021419BioPure 4400 RO42M16B2E2016-09-23
00817492021426BioPure 4400 RO42M16B2F 2016-09-23
00817492021433BioPure 4400 RO45M16B2E2016-09-23
00817492021440BioPure 4400 RO45M16B2F2016-09-23
00817492021457BioPure 4400 RO52M16B2E2016-09-23
00817492021464BioPure 4400 RO52M16B2F2016-09-23
00817492021471BioPure 4400 RO55M16B2E2016-09-23
00817492021488BioPure 4400 RO55M16B2F2016-09-23
00817492021495BioPure 4400 RO62M16B2E2016-09-23
00817492021501BioPure 4400 RO62M16B2F2016-09-23

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