ACCUSOL Dialysis Solution for CRRT 5B9248

GUDID 09349285000154

Accusol 35 4K+ Solution is indicated for use as a dialysis solution in Continuous Renal Replacement Therapy.

Nikkiso Belgium BVBA

Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate

Primary Device ID	09349285000154
NIH Device Record Key	8bf94465-8f57-48ad-9042-b42abd2386a4
Commercial Distribution Discontinuation	2022-05-31
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	ACCUSOL Dialysis Solution for CRRT
Version Model Number	35 4K+
Catalog Number	5B9248
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	09349285000154 [Primary]
GS1	19349285000151 [Package] Package: case [4 Units] Discontinued: 2022-05-31 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	4
Public Version Date	2022-07-04
Device Publish Date	2016-06-30

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