FDA.reportPublic FDA data

AcetiCon

Primary DI
00810104850087
Brand
AcetiCon
Company
Global Scientific Technologies
Model
AC2037-55-L
Catalog number
AC2037-55-L
Device description
AcetiCon Liquid Acid Concentrate for Bicarbonate Dialysis
Published
2022-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810104850087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810104850087008101048500878101048500870810104850087

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis concentrateA product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume208Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep container tightly closed when not in use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
864-655-3590productinfo@gst-us.com

Regulatory Flags#

DUNS number
032473859
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810104850001AcetiConAC2034-01-LAC2034-01-L2022-03-10
00810104850032AcetiConAC2035-01-LAC2035-01-L2022-03-10
00810104850018AcetiConAC2034-01-LAC2034-01-L2022-03-10
00810104850025AcetiConAC2034-55-LAC2034-55-L2022-03-10
00810104850049AcetiConAC2035-01-LAC2035-01-L2022-03-10
00810104850056AcetiConAC2035-55-LAC2035-55-L2022-03-10
00810104850063AcetiConAC2037-01-LAC2037-01-L2022-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840861103086BicarbyFresenius Medical Care Renal Therapies Group, LLCKPO2025-12-18
10840861103093BicarbyFresenius Medical Care Renal Therapies Group, LLCKPO2025-12-18
10840861103109BicarbyFresenius Medical Care Renal Therapies Group, LLCKPO2025-12-18
10840861103116BicarbyFresenius Medical Care Renal Therapies Group, LLCKPO2025-12-18
10840861103123BicarbyFresenius Medical Care Renal Therapies Group, LLCKPO2025-12-18
00814963021503CitraPureROCKWELL MEDICAL, INC.KPO2025-07-28
10840861102911BicarbyFresenius Medical Care Renal Therapies Group, LLCKPO2025-06-02
10840861102942BicarbyFresenius Medical Care Renal Therapies Group, LLCKPO2025-05-05
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10840861102829BicarbyFresenius Medical Care Renal Therapies Group, LLCKPO2024-10-10
00840861102839BicarbyFresenius Medical Care Renal Therapies Group, LLCKPO2024-10-10
10840861102843BicarbyFresenius Medical Care Renal Therapies Group, LLCKPO2024-10-10
10840861102850BicarbyFresenius Medical Care Renal Therapies Group, LLCKPO2024-10-10
10840861102768PureFlowFresenius Medical Care Renal Therapies Group, LLCKPO2024-05-30
10840861102775PureFlowFresenius Medical Care Renal Therapies Group, LLCKPO2024-05-30
10840861102782PureFlowFresenius Medical Care Renal Therapies Group, LLCKPO2024-05-30
10840861102799PureFlowFresenius Medical Care Renal Therapies Group, LLCKPO2024-05-30
00817411023197Citric CompleteNIPRO RENAL SOLUTIONS USA CORPORATIONKPO2024-05-22
10814963020732CitraPureROCKWELL MEDICAL, INC.KPO2024-04-18
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10817411023101Citric CompleteNIPRO RENAL SOLUTIONS USA CORPORATIONKPO2024-03-28
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10817411023125Citric CompleteNIPRO RENAL SOLUTIONS USA CORPORATIONKPO2024-03-28