PeraSidual 1702-01

GUDID 00898021000235

Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid.

Angelini Pharma Inc.

Hydrogen peroxide device disinfectant/sterilant test strip
Primary Device ID00898021000235
NIH Device Record Key6c5c652b-61e0-41c2-992f-1512274f18b4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeraSidual
Version Model Number1702-01
Catalog Number1702-01
Company DUNS078843940
Company NameAngelini Pharma Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com
Phone800-726-2308
Emailcustomerservice@angelini-us.com

Device Dimensions

Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch
Length3.25 Inch
Width0.2 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100898021000235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIFDialyzer Reprocessing System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-02-15
Device Publish Date2017-05-23

Devices Manufactured by Angelini Pharma Inc.

20898021000383 - Peracidin®2024-04-01 Dialyzer Reprocessing Concentrate and RO Disinfectant
20898021000406 - Peracidin®2024-04-01 Dialyzer Reprocessing Concentrate and RO Disinfectant
00898021000419 - Peracidin®2024-04-01 Dialyzer Reprocessing Concentrate and RO Disinfectant
00898021000037 - Maky 21.12023-02-15 Dialyzer reprocessing machine.
00898021000181 - Peracidin™2023-02-15 PAA Dialyzer Disinfectant.
00898021000228 - Peracidin™2023-02-15 PAA Dialyzer Disinfectant.
00898021000204 - Peracidin™2023-02-15 PAA Dialyzer Disinfectant.
00898021000235 - PeraSidual2023-02-15Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid.
00898021000235 - PeraSidual2023-02-15 Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines dis

Trademark Results [PeraSidual]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PERASIDUAL
PERASIDUAL
77776887 3786979 Live/Registered
ANGELINI PHARMA INC.
2009-07-08
PERASIDUAL
PERASIDUAL
75519204 not registered Dead/Abandoned
ViAtro, Corp.
1998-07-15

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