Peracid Test

Primary DI
G212HP20401
Brand
Peracid Test
Company
Ibt Scientific LLC
Model
HP20401
Device description
1 bottle of 100 test strips to detect peracetic acid
Published
2022-01-06
Public version status
Update
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
K964264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964264000HIGH RANGE PEROXIDE TEST STRIPIntegrated Biomedical Technology, Inc.1997-06-16FKP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G212HP20401PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection solution 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 the active ingredient in a device disinfectant and/or sterilant solution after preparation, to ensure disinfectant/sterilant properties. 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

Sterilization Methods#

Method table
Method

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
G212CM20201WaterCheck2CM202012022-01-06
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
G212CM20201WaterCheck2Ibt Scientific LLCFKP2022-01-06
G212CP20101WaterCheckCPIbt Scientific LLCFKP2022-01-06
G212PX20501RenalCheck PXIbt Scientific LLCFKP2022-01-06
G212RC22101WaterCheckRCIbt 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