FDA UDI
In Commercial Distribution
🇺🇸 United States
SteriChek® Peroxide Reagent Strips
DI: 00851575007044
·
Model: 811905
·
HACH COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- SteriChek® Peroxide Reagent Strips
- Primary DI
- 00851575007044
- Version / Model
- 811905
- Catalog Number
- 811905
- Company Name
- HACH COMPANY
- Labeler DUNS
- 091381780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2018-09-12
- Public Version Status
- Update
- Public Device Record Key
- 4efbb3c4-1f3f-4996-89d8-2c4809df7f24
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LIF | Dialyzer Reprocessing System | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58107 | Hydrogen peroxide device disinfectant/sterilant test strip | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851575007044 | GS1 | ||||
| Unit of Use | 00851575007037 | GS1 |
Customer Contacts
- Phone
- 1-970-278-4951
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K974798 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 0.2 | Inch | |
| Length | 3.25 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
- Type
- Storage Environment Temperature
- Temperature Range
- 60 – 90 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 60 – 90 Degrees Fahrenheit