PeraSidual

Primary DI
00898021000235
Brand
PeraSidual
Company
Angelini Pharma Inc.
Model
1702-01
Catalog number
1702-01
Device description
Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid.
Published
2017-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LIFDialyzer Reprocessing System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIFDialyzer Reprocessing SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974798000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974798000STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPSEnvironmental Test Systems, Inc.1998-03-20LIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00898021000235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00898021000235008980210002358980210002350898021000235

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.25Inch
Width0.2Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature60 Degrees Fahrenheit90 Degrees Fahrenheit
Special Storage Condition, Specify00Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment Temperature60 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-726-2308customerservice@angelini-us.com

Regulatory Flags#

DUNS number
078843940
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00898021000389Peracidin®Gallon0818942024-03-22
00898021000402Peracidin®Quarts0818982024-03-22
20898021000383Peracidin®Gallon0818942024-03-22
20898021000406Peracidin®Quarts0818982024-03-22
00898021000419Peracidin®Drum0818962024-03-22
00898021000051Alcavis 50500 mL155012016-08-29
00898021000044Alcavis 50250 mL155082016-08-29
00898021000068Alcavis 50200 mL Spray155022016-08-29
00898021000075ExSept Plus500 mL151172016-08-29
00898021000105ExSept Plus100 mL151042016-08-29
00898021000198Peracidin™Gallon1632-042016-08-29
00898021000297Peracidin RO DisinfectantQuarts1633Q2017-08-04
00898021000037Maky 21.121.1MAKY21.12016-08-29
00898021000181Peracidin™Quarts1632-122016-08-29
00898021000228Peracidin™Gallon1632-042016-08-29
00898021000204Peracidin™Drum1632-552016-08-29
00898021000242PeraChek1701-011701-012017-05-23
00898021000310Peracidin RO DisinfectantQuarts1633Q2017-08-04
00898021000303Peracidin RO DisinfectantGallon1633G2017-08-04
00898021000372Amekina 200 ML Spray419842 2023-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G212GT23101GlutarTest 1Ibt Scientific LLCLIF2022-01-06
00851575007389Stericide Peroxide Reagent StripsHACH COMPANYLIF2020-04-14
00677964007972Renalin Residual Test StripsMEDIVATORS INC.LIF2018-07-09
10677964007979Renalin Residual Test StripsMEDIVATORS INC.LIF2018-07-09
10677964009119Perassay 500 Peracetic Acid Test StripsMEDIVATORS INC.LIF2018-07-09
00898021000242PeraChekAngelini Pharma Inc.LIF2017-05-23
00382830034456NATUS NEUROLOGY NATUS NEUROLOGY INCORPORATEDLIF2017-03-17
00858293006120Micro-XREPROCESSING PRODUCTS CORPORATIONLIF2017-03-07
00851575007044SteriChek® Peroxide Reagent StripsHACH COMPANYLIF2016-09-23
00851575007075SteriChek® Residual Peroxide Reagent StripsHACH COMPANYLIF2016-09-23
00851575007150SteriChek® Peracetic Acid Reagent StripsHACH COMPANYLIF2016-09-23
M17451051Serim® GUARDIAN™ Residual Peroxide Test Strips SERIM RESEARCH CORPORATIONLIF2016-09-08
M17451052Serim® GUARDIAN™ Residual Peroxide Test Strips SERIM RESEARCH CORPORATIONLIF2016-09-08
M17451121Serim® GUARDIAN™ Residual Formaldehyde Test Strips SERIM RESEARCH CORPORATIONLIF2016-09-08
00898021000037Maky 21.1Angelini Pharma Inc.LIF2016-08-29