HEMODIALYSIS DELIVERY SYSTEM

GUDID 04987671060006

The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure

NIKKISO CO.,LTD.

Haemodialysis system dialysate delivery unit

• Primary Device ID: 04987671060006
• NIH Device Record Key: f20b6d6b-36f8-42ae-b9bb-fb59a9a0bd31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEMODIALYSIS DELIVERY SYSTEM
• Version Model Number: DBB-06
• Company DUNS: 690542378
• Company Name: NIKKISO CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx
• Phone: +81334433727
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Fahrenheit and 35 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987671060006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152938

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-12

On-Brand Devices [HEMODIALYSIS DELIVERY SYSTEM]

• 04987671060006: The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians f
• 04987671041517: The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians f