FDA.reportPublic FDA data

RenalCheck PX

Primary DI
G212PX20501
Brand
RenalCheck PX
Company
Ibt Scientific LLC
Model
PX20501
Device description
1 bottle of 100 test strips to check peroxide residue in rinse water
Published
2022-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FKPSystem, Dialysate Delivery, Single Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKPSystem, Dialysate Delivery, Single PatientGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953854000WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDEIntegrated Biomedical Technology, Inc.1996-03-11FKP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G212PX20501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hydrogen peroxide device disinfectant/sterilant test stripA sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of hydrogen peroxide (H2O2) in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
016808871
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G212WS20301WaterSoftWS203012025-12-12
G212WS21350WaterSoft 0-30WS213502025-12-12
G212HP20401Peracid TestHP204012022-01-06
G212CM20201WaterCheck2CM202012022-01-06
G212CP20101WaterCheckCPCP201012022-01-06
G212GT23101GlutarTest 1GT231012022-01-06
G212RC22101WaterCheckRCRC221012022-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G212CM20201WaterCheck2Ibt Scientific LLCFKP2022-01-06
G212CP20101WaterCheckCPIbt Scientific LLCFKP2022-01-06
G212RC22101WaterCheckRCIbt Scientific LLCFKP2022-01-06
G212HP20401Peracid TestIbt Scientific LLCFKP2022-01-06
00842289101883NX2ME APPNXSTAGE MEDICAL, INC.FKP2019-02-15
00842289101890NX2ME CLINICIAN PORTALNXSTAGE MEDICAL, INC.FKP2019-02-15
M535NX1225NX1379Nx2me Connected Health Nx2me AppNXSTAGE MEDICAL, INC.FKP2015-09-01
M535NX1225NX1380Nx2me Connected Health Nx2me Clinician PortalNXSTAGE MEDICAL, INC.FKP2015-09-01
M535NX1272NxStage Dosing CalculatorNXSTAGE MEDICAL, INC.FKP2015-09-01