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 Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip Hydrogen peroxide device disinfectant/sterilant test strip| Primary Device ID | 00898021000235 |
| NIH Device Record Key | 6c5c652b-61e0-41c2-992f-1512274f18b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PeraSidual |
| Version Model Number | 1702-01 |
| Catalog Number | 1702-01 |
| Company DUNS | 078843940 |
| Company Name | Angelini Pharma Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com | |
| Phone | 800-726-2308 |
| customerservice@angelini-us.com |
Device Dimensions
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
| Length | 3.25 Inch |
| Width | 0.2 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack. |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00898021000235 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K974798
FDA Product Code
| LIF | Dialyzer Reprocessing System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-02-15 |
| Device Publish Date | 2017-05-23 |
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 21.1 | 2023-02-15 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 - PeraSidual | 2023-02-15Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid. |
| 00898021000235 - PeraSidual | 2023-02-15 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 77776887 3786979 Live/Registered |
ANGELINI PHARMA INC. 2009-07-08 |
 PERASIDUAL 75519204 not registered Dead/Abandoned |
ViAtro, Corp. 1998-07-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.