FDA UDI
In Commercial Distribution
🇺🇸 United States
Serim® GUARDIAN™ Peracetic Acid Test Strips
DI: M17451061
·
Model: 5106
·
SERIM RESEARCH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Serim® GUARDIAN™ Peracetic Acid Test Strips
- Primary DI
- M17451061
- Version / Model
- 5106
- Catalog Number
- 5106
- Company Name
- SERIM RESEARCH CORPORATION
- Labeler DUNS
- 605151018
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-08
- Public Version
- 4
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- 3dcb736e-b1a5-4059-9200-26fc94ce2725
Device Description
SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing concentrates such as Renalin® Cold Sterilant, PerAldecide™, Puristeril® 340, Peracidin™ and Micro-X®.
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 |
|---|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58056 | Medical device disinfection solution 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 the active ingredient in a device disinfectant and/or sterilant solution after preparation, to ensure disinfectant/sterilant properties. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M17451061 | HIBCC | ||||
| Unit of Use | M17451060 | HIBCC | ||||
| Package | M17451062 | HIBCC | Kit | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-542-4670
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius