SteriChek® Blood Leak Reagent Strips 812145
GUDID 00851575007129
Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodialysis procedure.
HACH COMPANY
Haemodialysis system blood leak detector| Primary Device ID | 00851575007129 |
| NIH Device Record Key | 99ff205b-df4a-4d56-aaec-96150a9ec45a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SteriChek® Blood Leak Reagent Strips |
| Version Model Number | 812014 |
| Catalog Number | 812145 |
| Company DUNS | 091381780 |
| Company Name | HACH COMPANY |
| Device Count | 10 |
| 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 | 1-970-278-4951 |
| etscustomerservice@hach.com | |
| Phone | 1-970-278-4951 |
| etscustomerservice@hach.com | |
| Phone | 1-970-278-4951 |
| etscustomerservice@hach.com | |
| Phone | 1-970-278-4951 |
| etscustomerservice@hach.com | |
| Phone | 1-970-278-4951 |
| etscustomerservice@hach.com | |
| Phone | 1-970-278-4951 |
| etscustomerservice@hach.com | |
| Phone | 1-970-278-4951 |
| etscustomerservice@hach.com | |
| Phone | 1-970-278-4951 |
| etscustomerservice@hach.com | |
| Phone | 1-970-278-4951 |
| etscustomerservice@hach.com | |
| Phone | 1-970-278-4951 |
| etscustomerservice@hach.com | |
| Phone | 1-970-278-4951 |
| etscustomerservice@hach.com | |
| Phone | 1-970-278-4951 |
| etscustomerservice@hach.com | |
| Phone | 1-970-278-4951 |
| etscustomerservice@hach.com |
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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851575007099 [Unit of Use] |
| GS1 | 00851575007112 [Primary] |
| GS1 | 00851575007129 [Package] Contains: 00851575007112 Package: Case [324 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042322
FDA Product Code
| FJD | Detector, Leak, Blood |
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 | 2016-10-28 |
On-Brand Devices [SteriChek® Blood Leak Reagent Strips]
| 00851575007129 | Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodia |
| 00851575007105 | Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodia |
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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