Hemodialysis Delivery System

GUDID 24987671041702

The DBB-06 PRO 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 PRO Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.

NIKKISO CO.,LTD.

Haemodialysis system dialysate delivery unit

• Primary Device ID: 24987671041702
• NIH Device Record Key: f70d5967-6080-4147-a98d-f82791a8da1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemodialysis Delivery System
• Version Model Number: DBB-06 PRO
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Disinfect and drain before storing. Store upright in a well-ventilated room with minimal temperature fluctuations. Charge the battery every six months and after each storage period.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Disinfect and drain before storing. Store upright in a well-ventilated room with minimal temperature fluctuations. Charge the battery every six months and after each storage period.
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Disinfect and drain before storing. Store upright in a well-ventilated room with minimal temperature fluctuations. Charge the battery every six months and after each storage period.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987671041708 [Primary]
GS1	24987671041702 [Package]; Contains: 04987671041708; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242155

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-01
• Device Publish Date: 2025-08-22

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
• 24987671041702: The DBB-06 PRO Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicia