SteriChek® Peracetic Acid Reagent Strips 811906
GUDID 00851575007150
Reagent test strip for measuring the concentration of peracetic acid in dialyzer reprocessing.
HACH COMPANY
Peracetic acid device disinfectant/sterilant test strip| Primary Device ID | 00851575007150 |
| NIH Device Record Key | 47724838-841c-462f-899e-f57e6e133cd8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SteriChek® Peracetic Acid Reagent Strips |
| Version Model Number | 811906 |
| Catalog Number | 811906 |
| Company DUNS | 091381780 |
| Company Name | HACH COMPANY |
| Device Count | 600 |
| 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
Device Dimensions
| Length | 3.25 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 |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling 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 |
| 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 | 00851575007082 [Unit of Use] |
| GS1 | 00851575007150 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K980164
FDA Product Code
| MSY | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
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 | 2018-09-12 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by HACH COMPANY
| 00851575007389 - Stericide Peroxide Reagent Strips | 2020-04-22 Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines dis |
| 00851575007020 - SteriChek® Residual Chlorine Reagent Strips | 2018-09-12 Reagent test strip for measuring the concentration of residual chlorine (i.e. from chlorine bleach) in rinse water following dis |
| 00851575007044 - SteriChek® Peroxide Reagent Strips | 2018-09-12 Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines dis |
| 00851575007051 - SteriChek® Total Chlorine Test Kit | 2018-09-12 Reagent test kit used to measure low levels of total chlorine in feed water used to prepare dialysate. |
| 00851575007068 - Sterichek® Total Chlorine Test Kit Refill | 2018-09-12 DPD reagent powder pillows refill, used with reagent test kit to measure low levels of total chlorine in feed water used to prep |
| 00851575007075 - SteriChek® Residual Peroxide Reagent Strips | 2018-09-12 Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines dis |
| 00851575007105 - SteriChek® Blood Leak Reagent Strips | 2018-09-12 Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodialysis procedure. |
| 00851575007129 - SteriChek® Blood Leak Reagent Strips | 2018-09-12 Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodialysis procedure. |
Trademark Results [SteriChek]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERICHEK 76205017 2658130 Live/Registered |
Hach Company 2001-02-02 |
 STERICHEK 75353982 not registered Dead/Abandoned |
Environmental Test Systems, Inc. 1997-09-09 |
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