FDA.reportPublic FDA data

WaterCheck2

Primary DI
G212CM20201
Brand
WaterCheck2
Company
Ibt Scientific LLC
Model
CM20201
Device description
1 bottle of 100 test strips to check residual chlorine 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
G212CM20201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis equipment residual chlorine test stripA sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change and visual comparison to a colour chart, the concentration of residual chlorine in water samples. It is typically used as a means to test whether chlorine has been adequately rinsed from haemodialysis equipment following disinfection. 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
G212CP20101WaterCheckCPCP201012022-01-06
G212GT23101GlutarTest 1GT231012022-01-06
G212PX20501RenalCheck PXPX205012022-01-06
G212RC22101WaterCheckRCRC221012022-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G212CP20101WaterCheckCPIbt Scientific LLCFKP2022-01-06
G212PX20501RenalCheck PXIbt 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