ACCUSOL Dialysis Solution for CRRT 5B9250

GUDID 09349285000178

Accusol 35 0K+ 0DEX Solution is indicated for use as dialysis solution in Continuous Renal Replacement Therapy.

Nikkiso Belgium BVBA

Haemodialysis concentrate

• Primary Device ID: 09349285000178
• NIH Device Record Key: 539da9a0-f019-453a-b65c-bb618233fa10
• Commercial Distribution Discontinuation: 2019-03-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ACCUSOL Dialysis Solution for CRRT
• Version Model Number: 35 0K+ 0DEX
• Catalog Number: 5B9250
• Company DUNS: 370482633
• Company Name: Nikkiso Belgium BVBA
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3216781779
• Email: regulatory@nikkisomedical.com
• Phone: +3216781779
• Email: regulatory@nikkisomedical.com
• Phone: +3216781779
• Email: regulatory@nikkisomedical.com
• Phone: +3216781779
• Email: regulatory@nikkisomedical.com
• Phone: +3216781779
• Email: regulatory@nikkisomedical.com
• Phone: +3216781779
• Email: regulatory@nikkisomedical.com
• Phone: +3216781779
• Email: regulatory@nikkisomedical.com
• Phone: +3216781779
• Email: regulatory@nikkisomedical.com

Device Dimensions

• Total Volume: 2500 Milliliter
• Total Volume: 2500 Milliliter
• Total Volume: 2500 Milliliter
• Total Volume: 2500 Milliliter
• Total Volume: 2500 Milliliter
• Total Volume: 2500 Milliliter
• Total Volume: 2500 Milliliter
• Total Volume: 2500 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (25 °C/77 °F). Avoid excessive heat. Brief exposure up to 40 °C (104 °F) does not adversely affect the product. Protect from freezing.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (25 °C/77 °F). Avoid excessive heat. Brief exposure up to 40 °C (104 °F) does not adversely affect the product. Protect from freezing.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (25 °C/77 °F). Avoid excessive heat. Brief exposure up to 40 °C (104 °F) does not adversely affect the product. Protect from freezing.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (25 °C/77 °F). Avoid excessive heat. Brief exposure up to 40 °C (104 °F) does not adversely affect the product. Protect from freezing.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (25 °C/77 °F). Avoid excessive heat. Brief exposure up to 40 °C (104 °F) does not adversely affect the product. Protect from freezing.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (25 °C/77 °F). Avoid excessive heat. Brief exposure up to 40 °C (104 °F) does not adversely affect the product. Protect from freezing.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (25 °C/77 °F). Avoid excessive heat. Brief exposure up to 40 °C (104 °F) does not adversely affect the product. Protect from freezing.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (25 °C/77 °F). Avoid excessive heat. Brief exposure up to 40 °C (104 °F) does not adversely affect the product. Protect from freezing.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349285000178 [Primary]
GS1	19349285000175 [Package]; Package: case [4 Units]; Discontinued: 2019-03-20; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041428

FDA Product Code

• KPO: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-07-04
• Device Publish Date: 2016-06-30

On-Brand Devices [ACCUSOL Dialysis Solution for CRRT]

• 09349285000178: Accusol 35 0K+ 0DEX Solution is indicated for use as dialysis solution in Continuous Renal Repla
• 09349285000161: Accusol 35 2K+ Solution is indicated for use as dialysis solution in Continuous Renal Replacemen
• 09349285000154: Accusol 35 4K+ Solution is indicated for use as a dialysis solution in Continuous Renal Replacem