ACCUSOL Dialysis Solution for CRRT 5B9249

GUDID 09349285000161

Accusol 35 2K+ Solution is indicated for use as dialysis solution in Continuous Renal Replacement Therapy.

Nikkiso Belgium BVBA

Haemodialysis concentrate
Primary Device ID09349285000161
NIH Device Record Keyd9038ca7-d0e2-4765-bf99-3bf721755143
Commercial Distribution Discontinuation2022-06-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameACCUSOL Dialysis Solution for CRRT
Version Model Number35 2K+
Catalog Number5B9249
Company DUNS370482633
Company NameNikkiso Belgium BVBA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+3216781779
Emailregulatory@nikkisomedical.com
Phone+3216781779
Emailregulatory@nikkisomedical.com
Phone+3216781779
Emailregulatory@nikkisomedical.com
Phone+3216781779
Emailregulatory@nikkisomedical.com
Phone+3216781779
Emailregulatory@nikkisomedical.com
Phone+3216781779
Emailregulatory@nikkisomedical.com
Phone+3216781779
Emailregulatory@nikkisomedical.com
Phone+3216781779
Emailregulatory@nikkisomedical.com

Device Dimensions

Total Volume2500 Milliliter
Total Volume2500 Milliliter
Total Volume2500 Milliliter
Total Volume2500 Milliliter
Total Volume2500 Milliliter
Total Volume2500 Milliliter
Total Volume2500 Milliliter
Total Volume2500 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 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 TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 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 TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS109349285000161 [Primary]
GS119349285000168 [Package]
Package: case [4 Units]
Discontinued: 2022-06-30
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-07-04
Device Publish Date2016-06-30

On-Brand Devices [ACCUSOL Dialysis Solution for CRRT]

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

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