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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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K1000 - B210AC0290

K1000 is a 3-electrode personal EKG device that is capable of recording a 6-Lead EKG, which provides the healthcare professional more data than a single lead EKG. K1000 has two electrodes on the top surface and one on the bottom surface. It is powered by a replaceable battery, which is located under the bottom electrode. Bluetooth is used to wirelessly transmit EKG data from the device to a smartphone or tablet. K1000 is available by prescription only.
Alivecor, Inc.
AC-029
In Commercial Distribution

  • B210AC0290 ()


  • Electrocardiograph, professional, single-channel

CitriSol - B467CSP3522510100

CitriSol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CSP35225-10100
In Commercial Distribution

  • B467CSP352251010025 ()
  • B467CSP3522510100 ()
CSP1

  • Haemodialysis concentrate

CitriSol - B467CSP4512575100

CitriSol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CSP45125-75100
In Commercial Distribution

  • B467CSP451257510016 ()
  • B467CSP4512575100 ()
CSP2

  • Haemodialysis concentrate

DRYASOL - B467ACP4532575100

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45325-75100
In Commercial Distribution

  • B467ACP453257510016 ()
  • B467ACP4532575100 ()
ACP11

  • Haemodialysis concentrate

DRYASOL - B467ACP4522575200

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45225-75200
In Commercial Distribution

  • B467ACP452257520025 ()
  • B467ACP4522575200 ()
ACP12

  • Haemodialysis concentrate

DRYASOL - B467ACP4522575100

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45225-75100
In Commercial Distribution

  • B467ACP452257510016 ()
  • B467ACP4522575100 ()
  • B467ACP452257510020 ()
  • B467ACP452257510025 ()
ACP8/9/10

  • Haemodialysis concentrate

DRYASOL - B467ACP4512575100

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45125-75100
In Commercial Distribution

  • B467ACP451257510016 ()
  • B467ACP4512575100 ()
  • B467ACP451257510025 ()
ACP6/7

  • Haemodialysis concentrate

DRYASOL - B467ACP3623510200

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
36235-10200
In Commercial Distribution

  • B467ACP362351020025 ()
  • B467ACP3623510200 ()
  • B467ACP362351020033 ()
ACP4

  • Haemodialysis concentrate

DRYASOL - B467ACP3622510200

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
36225-10200
In Commercial Distribution

  • B467ACP362251020025 ()
  • B467ACP3622510200 ()
ACP3

  • Haemodialysis concentrate

DRYASOL - B467ACP3622010200

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
36220-10200
In Commercial Distribution

  • B467ACP362201020025 ()
  • B467ACP3622010200 ()
ACP2

  • Haemodialysis concentrate
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