Identity
- Trade Name
- QwikCheck® FDA UDI
- Generic Name
- Medical device disinfection solution test strip FDA UDI
- Device Name
- The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm. FDA UDI
- Model / Reference
- 202790 FDA UDI
- Description
- The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm. FDA UDI
Identifiers
- Catalog Number
- CS-202790 FDA UDI
- Primary DI / UDI-DI
- B205CS2027901 FDA UDI
- 510(k) Number
- K230381 FDA UDI
- FDA Product Code
- JOJ FDA UDI
- GMDN Term
- Medical device disinfection solution test strip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device disinfection solution test strip
QwikCheck® by Cs Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230381 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cs Medical Llc
Sources (1)
- FDA UDI 3e3ebe65-bfba-4a4b-be1a-790bb6986adc 35 fields · synced Jun 8, 2026