myronl.comDIALYSATE METER, MODEL D-6
MYRON L COMPANY
MYRON L COMPANY
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2020976 | 2020976 | MYRON L COMPANY | 1 | N | 2026-01-01 | 2450 IMPALA DR. CARLSBAD CA US 92010 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00857744006009 | Myron L® Company - A handheld, analog instrument that measures conductivity of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the conductivity of dialysate and is a Class II medical device. The D-1 has an analog scale of 11-15 millimhos. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type. | 1-760-438-2021 | techquestions@myronl.com |
| 00857744006016 | Myron L® Company - A handheld, analog instrument that measures conductivity of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the conductivity of dialysate and is a Class II medical device. The D-2 features dual scales and can be used to test both acetate and bicarbonate dialysate. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type. | 1-760-438-2021 | techquestions@myronl.com |
| 00857744006023 | Myron L® Company - 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. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type. | 1-760-438-2021 | techquestions@myronl.com |
| 00857744006030 | Myron L® Company - 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. | 1-760-438-2021 | techquestions@myronl.com |
| 00857744006047 | Myron L® Company - A handheld, multi-function, digital device that measures conductivity, pH, Temperature, and ORP of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the temperature conductivity and pH of dialysate and a Class II medical device. It can test both acetate and bicarbonate dialysate quality. It can also be used to test the quality of dialysis feed water. Internal sensors require the user to place the sample in the instrument, preventing contamination of dialysate by the measurement device. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type. | 1-760-438-2021 | techquestions@myronl.com |
| 00857744006054 | Myron L® Company - A handheld, multi-function, digital device that measures conductivity, pH, Temperature, and ORP of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the temperature conductivity and pH of dialysate and a Class II medical device. It can test both acetate and bicarbonate dialysate quality. It can also be used to test the quality of dialysis feed water. 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 | 1-760-438-2021 | techquestions@myronl.com |
| 00857744006061 | Myron L® Company - 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. | 1-760-438-2021 | techquestions@myronl.com |
| 00857744006078 | Myron L® Company - 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. | 1-760-438-2021 | techquestions@myronl.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 34130 | 1266649811 | K100237 | DIALYSATE METER, MODEL D-6 | FLB | 2010-04-23 |
| 34130 | 1711533328 | ||||
| 34130 | 1894991099 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FLB | 1 | 2010-04-23 |
PMN#
GUDID#
Myron L® Company - 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. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type.
2016-09-23
Myron L® Company - 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.
2016-09-23
Myron L® Company - A handheld, multi-function, digital device that measures conductivity, pH, Temperature, and ORP of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the temperature conductivity and pH of dialysate and a Class II medical device. It can test both acetate and bicarbonate dialysate quality. It can also be used to test the quality of dialysis feed water. Internal sensors require the user to place the sample in the instrument, preventing contamination of dialysate by the measurement device. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type.
2016-09-23
Myron L® Company - A handheld, multi-function, digital device that measures conductivity, pH, Temperature, and ORP of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the temperature conductivity and pH of dialysate and a Class II medical device. It can test both acetate and bicarbonate dialysate quality. It can also be used to test the quality of dialysis feed water. 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
2016-09-23
Myron L® Company - A handheld, analog instrument that measures conductivity of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the conductivity of dialysate and is a Class II medical device. The D-1 has an analog scale of 11-15 millimhos. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type.
2016-09-23
Myron L® Company - A handheld, analog instrument that measures conductivity of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the conductivity of dialysate and is a Class II medical device. The D-2 features dual scales and can be used to test both acetate and bicarbonate dialysate. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type.
2016-09-23
Myron L® Company - 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.
2016-09-23
Myron L® Company - 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.
2016-09-23
Myron L® Company - 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.
2016-09-23
Myron L® Company - 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.
2016-09-23
Myron L® Company - 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.
2016-09-23
Myron L® Company - 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.
2016-09-23
Myron L® Company - 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.
2016-09-23
Myron L® Company - An accessory for the D-6 Dialysate Meter™. A hard case, foam-lined protective carrying case.Contains 1 (one) each 2 oz bottle of 14.0 millimohs, NaCl Standard Solution (P/N NACL-14.02OZ; UDI# 00857744006108). This is the only listed component included this item. The D-6 Dialysate Meter™ is packaged separately.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.
2016-09-23