Identity
- Trade Name
- Myron L® Company FDA UDI
- Generic Name
- Haemodialysis conductivity standard solution FDA UDI
- Device Name
- NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis. FDA UDI
- Model / Reference
- Solution, NaCl, 12.5 Millimhos, Gallon FDA UDI
- Description
- NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis. FDA UDI
Identifiers
- Catalog Number
- NACL-12.5G FDA UDI
- Primary DI / UDI-DI
- 00857744006078 FDA UDI
- FDA Product Code
- FKH FDA UDI
- GMDN Term
- Haemodialysis conductivity standard solution 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Gallon FDA UDI
Category: Haemodialysis conductivity standard solution
Myron L® Company by Myron L Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 6667ebcf-2e13-4c2d-be75-2a61e4f946d0 37 fields · synced Jun 6, 2026