FDA UDI
In Commercial Distribution
🇺🇸 United States
Tristel Test Strips
DI: 05060171914686
·
Model: 45-13
·
TRISTEL SOLUTIONS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tristel Test Strips
- Primary DI
- 05060171914686
- Version / Model
- 45-13
- Company Name
- TRISTEL SOLUTIONS LIMITED
- Labeler DUNS
- 235192791
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-03
- Public Version
- 2
- Public Version Date
- 2024-04-16
- Public Version Status
- Update
- Public Device Record Key
- 79e898b4-1853-4904-8510-91740b95794b
Device Description
The Tristel Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of the Tristel ULT high level disinfectant foam is above or below the minimum recommended concentration (MRC). A vial/bottle of 50 test strips. Stopwatch. Polyethylene container. 10ml measure syringe. User Guide.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| QWS | Foam Or Gel Chemical Sterilant/High Level Disinfectant | General Hospital | 880.6886 | 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 | 05060171914686 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN220041 | 000 |