NIKKISO CO.,LTD.

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Device Description : The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients only with acute or chronic renal failure. The DBB-06 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified, trained operator only.

Device Class : 2

Duns Number: 690542378

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.

Device Class : 2

Duns Number: 690542378

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : The BLOOD TUBING LINES FOR HEMODIALYS IS includes arterial and venous dialysis b The BLOOD TUBING LINES FOR HEMODIALYS IS includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures.They are manufactured for application with the NIKKISO DBB-06 Hemodialysis Delivery System.

Device Class : 2

Duns Number: 690542378

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1