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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Natus Medical Denmark ApS
1096,SA, DIAG W/ PRIN, COM US
In Commercial Distribution

  • 05713315005619 ()
8-04-16042

  • Impedance audiometer
Additional membrane filtration unit for AquaB LITE water purification system. B2 LITE 2500 for: AquaB LITE 3000 & B2 LITE 2500 The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
B2 LITE 2500
In Commercial Distribution

  • 04251285200623 ()


  • Reverse-osmosis water purification system
Additional membrane filtration unit for AquaB LITE water purification system. B2 LITE 2000 for: AquaB LITE 2500 & B2 LITE 2000 The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
B2 LITE 2000
In Commercial Distribution

  • 04251285200616 ()


  • Reverse-osmosis water purification system
Additional membrane filtration unit for AquaB LITE water purification system. B2 LITE 1500 for: AquaB LITE 2000 & B2 LITE 1500 The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
B2 LITE 1500
In Commercial Distribution

  • 04251285200609 ()


  • Reverse-osmosis water purification system
Additional membrane filtration unit for AquaB LITE water purification system. B2 LITE 1000 for: AquaB LITE 1500 & B2 LITE 1000 The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
B2 LITE 1000
In Commercial Distribution

  • 04251285200593 ()


  • Reverse-osmosis water purification system
Additional membrane filtration unit for AquaB LITE water purification system. B2 LITE 500 for: AquaB LITE 1000 & B2 LITE 500 The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
B2 LITE 500
In Commercial Distribution

  • 04251285200586 ()


  • Reverse-osmosis water purification system
Additional membrane filtration unit for AquaA water purification system. AquaA2 4000 for: AquaA 4000 & AquaA2 4000 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
AquaA2 4000
In Commercial Distribution

  • 04251285200425 ()


  • Reverse-osmosis water purification system
Additional membrane filtration unit for AquaA water purification system. AquaA2 3000 for: AquaA 3000 & AquaA2 3000 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
AquaA2 3000
In Commercial Distribution

  • 04251285200418 ()


  • Reverse-osmosis water purification system
Additional membrane filtration unit for AquaA water purification system. AquaA2 2000 for: AquaA 2000 & AquaA2 2000 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
AquaA2 2000
In Commercial Distribution

  • 04251285200401 ()


  • Reverse-osmosis water purification system
Additional membrane filtration unit for AquaA water purification system. AquaA2 1000 for: AquaA 2000 & AquaA2 1000 The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.
VIVONIC GmbH
AquaA2 1000
In Commercial Distribution

  • 04251285200395 ()


  • Reverse-osmosis water purification system
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