Blood Tubing Lines for Hemodialysis

GUDID 04987671100658

The BLOOD TUBING LINES FOR HEMODIALYSIS C18 series is one part of a blood tubing lines for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

NIKKISO CO.,LTD.

Haemodialysis blood tubing set, single-use

• Primary Device ID: 04987671100658
• NIH Device Record Key: 293755bd-9ee8-4caf-b7c0-b7467dcbb791
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Tubing Lines for Hemodialysis
• Version Model Number: C18SFD-E(U)
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location. Adoid direct sunlight. Do not store at extreme humidity.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location. Adoid direct sunlight. Do not store at extreme humidity.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location. Adoid direct sunlight. Do not store at extreme humidity.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987671100658 [Primary]
GS1	14987671100655 [Package]; Package: Box [50 Units]; In Commercial Distribution
GS1	24987671100652 [Package]; Contains: 14987671100655; Package: Box [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242176

FDA Product Code

• KOC: Accessories, Blood Circuit, Hemodialysis

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: 2025-09-01
• Device Publish Date: 2025-08-22

On-Brand Devices [Blood Tubing Lines for Hemodialysis]

• 24987671201106: The BLOOD TUBING LINES FOR HEMODIALYS IS includes arterial and venous dialysis blood tubing. The
• 04987671400000: The BLOOD TUBING LINES FOR HEMODIALYSIS AV06C-E includes arterial and venous dialysis blood tubi
• 04987671100658: The BLOOD TUBING LINES FOR HEMODIALYSIS C18 series is one part of a blood tubing lines for hemod
• 24987671100621: The BLOOD TUBING LINES FOR HEMODIALYSIS AL series(Sterilized by Ethylene Oxide) includes arteria