Filter for dialysate purification

GUDID 24987671030218

The EF-02D filter is a sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 23500. The filter(s) are used as part of Hemodialysis machine hydraulic section.

NIKKISO CO.,LTD.

Haemodialysis system dialysate pyrogen filter

• Primary Device ID: 24987671030218
• NIH Device Record Key: f5955818-0a4c-46e4-8f54-13b4fc249916
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Filter for dialysate purification
• Version Model Number: EF-02D
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
• 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

• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987671030214 [Primary]
GS1	24987671030218 [Package]; Contains: 04987671030214; Package: Box [6 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-15
• Device Publish Date: 2025-04-07

Devices Manufactured by NIKKISO CO.,LTD.

• 24987671030218 - Filter for dialysate purification: 2025-04-15The EF-02D filter is a sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 23500. The filter(s) are used as part of Hemodialysis machine hydraulic section.
• 24987671030218 - Filter for dialysate purification: 2025-04-15 The EF-02D filter is a sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 23500. The fi
• 04987671400000 - Blood Tubing Lines for Hemodialysis: 2023-09-05 The BLOOD TUBING LINES FOR HEMODIALYSIS AV06C-E includes arterial and venous dialysis blood tubing. The devices are packaged tog
• 24987671201106 - BLOOD TUBING LINES FOR HEMODIALYSIS: 2020-11-09 The BLOOD TUBING LINES FOR HEMODIALYS IS includes arterial and venous dialysis blood tubing. The devices are packaged together f
• 04987671041517 - HEMODIALYSIS DELIVERY SYSTEM: 2018-07-06 The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients only with acut
• 04987671060006 - HEMODIALYSIS DELIVERY SYSTEM: 2018-07-06 The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and