Blood Tubing Lines for Hemodialysis

GUDID 04987671400000

The BLOOD TUBING LINES FOR HEMODIALYSIS AV06C-E 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 DBB-06 Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and 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: 04987671400000
• NIH Device Record Key: ba07c3e2-9c00-4dd1-a1fa-0b06adc605ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Tubing Lines for Hemodialysis
• Version Model Number: AV06C-E
• 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: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp
• Phone: +81334433727
• Email: xxx@nikkiso.co.jp

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987671400000 [Primary]
GS1	24987671400004 [Package]; Package: Box [28 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231589

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: 2023-09-05
• Device Publish Date: 2023-08-28

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