Identity
- Trade Name
- Myron L® Company FDA UDI
- Generic Name
- Multi-parameter device tester FDA UDI
- Device Name
- A handheld, multi-function digital device that measures conductivity and temperature of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the temperature and conductivity of dialysate and a Class II medical device. It can test both acetate and bicarbonate dialysate quality. Internal sensors require the user to place the sample in the instrument, preventing contamination of dialysate by the measurement device. The BD version is equipped with a bluDock wireless communication module. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type. FDA UDI
- Model / Reference
- D-4 Digital Dialysate Meter™, bluDock Capable FDA UDI
- Description
- A handheld, multi-function digital device that measures conductivity and temperature of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the temperature and conductivity of dialysate and a Class II medical device. It can test both acetate and bicarbonate dialysate quality. Internal sensors require the user to place the sample in the instrument, preventing contamination of dialysate by the measurement device. The BD version is equipped with a bluDock wireless communication module. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type. FDA UDI
Identifiers
- Catalog Number
- D-4BD FDA UDI
- Primary DI / UDI-DI
- 00857744006030 FDA UDI
- 510(k) Number
- K100237 FDA UDI
- FDA Product Code
- FLB FDA UDI
- GMDN Term
- Multi-parameter device tester FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-parameter device tester
Myron L® Company by Myron L Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K100237 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
- Myron L Company
Sources (1)
- FDA UDI 63181245-927f-4f41-b935-d23554da6ff7 37 fields · synced May 30, 2026