Device Description : Sodium Bicarbonate for Hemodialysis
Device Class : 2
Duns Number: 354021099
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Prismaflex control unit is a software controlled single patient device that The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
Device Class : 2
Duns Number: 354021099
Premarket Exempt : No
Prescription Use : Yes
Device Description : Sodium Bicarbonate for Hemodialysis
Device Class : 2
Duns Number: 354021099
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Prismaflex control unit is a software controlled single patient device that The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
Device Class : 2
Duns Number: 354021099
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Prismaflex control unit is a software controlled single patient device that The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
Device Class : 2
Duns Number: 354021099
Premarket Exempt : No
Prescription Use : Yes
Device Description : Intended for intermittant haemodialysis and/or isolated ultrafiltration treatmen Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indicated to be used on patients with a body weight of 25 kg or more. To be used by trained operators in chronic care dialysis or hospital care environment. Not intended for Self-care or Home use.
Device Class : 2
Duns Number: 354021099
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Prismaflex control unit is a software controlled single patient device that The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
Device Class : 2
Duns Number: 354021099
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MARS Monitor is a mechanical detoxification device used in conjunction with The MARS Monitor is a mechanical detoxification device used in conjunction with a renal replacement therapy system (companion device) for the removal of dialyzable (unbound) toxins, which are either water-soluble or, in the bound form, associated with serum albumin.
Device Class : 2
Duns Number: 354021099
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MARS Treatment Kit type 1115/1-PrisMARS US is a set of disposable items to b The MARS Treatment Kit type 1115/1-PrisMARS US is a set of disposable items to be used with the MARS Monitor 1TC for performing MARS therapy, with exclusive use being made of the MARS Monitor 1TC in combination with the Prisma Control Unit (produced by Gambro).
Device Class : 2
Duns Number: 354021099
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be use The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with the Prismaflex device (produced by Gambro Lundia AB) for MARS therapy.
Device Class : 2
Duns Number: 354021099
Premarket Exempt : No
Prescription Use : Yes