FDA.reportPublic FDA data

Acid Dissolution System

Primary DI
00852456007115
Brand
Acid Dissolution System
Company
Isopure, Corp.
Model
MD70510
Device description
Dialysate Concentrate For Hemodialysis (Liquid or Powder)
Published
2024-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191093000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191093000Isopure Dry Acid Dissolution SystemIsopure, Corp.2020-01-22KPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852456007115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852456007115008524560071158524560071150852456007115

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040279650
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852456007108Acid Dissolution SystemMD705002024-02-14
00852456007009MD420 Reverse Osmosis SystemMD4202017-09-20
00852456007016MD440 Reverse Osmosis SystemMD4402017-09-20
00852456007023MD460 Reverse Osmosis SystemMD4602017-09-20
00852456007030MD470 Reverse Osmosis SystemMD4702017-09-20
00852456007047MD480 Reverse Osmosis SystemMD4802017-09-20
00852456007054MD490 Reverse Osmosis SystemMD4902017-09-20
00852456007078Complete Water Treatment System0012017-09-20
00852456007085Sodium Bicarbonate Mixing and Distribution SystemIsoMix PRO2017-09-20
00852456007092Acidified Concentrate Distribution and Storage (ACDS) SystemMD7042622017-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10857940006671Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2022-02-24
10857940006688Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2022-02-24
38051411600351HMB32HAEMOPHARM BIOFLUIDS SRLKPO2021-07-03
38051411600061HMB32HAEMOPHARM BIOFLUIDS SRLKPO2020-03-11
M535RFP211WW0NxStage PureFlow SolutionNXSTAGE MEDICAL, INC.KPO2018-10-01
10857940006664HEMO-DIALEDLAW PHARMACEUTICALS, INC.KPO2017-12-22
10857940006657Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2017-10-06
10857940006640Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2017-10-04
10857940006633Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2017-04-17
10857940006626Hemo-DialEDLAW PHARMACEUTICALS, INC.KPO2017-03-15
B46710013075100DIASOLDIASOL, INC.KPO2017-02-28
B46710020010100DIASOLDIASOL, INC.KPO2017-02-28
B46710021075100DIASOLDIASOL, INC.KPO2017-02-28
B46710021575100DIASOLDIASOL, INC.KPO2017-02-28
B46710023510100DIASOLDIASOL, INC.KPO2017-02-28
B46710031075100DIASOLDIASOL, INC.KPO2017-02-28
B46710031575100DIASOLDIASOL, INC.KPO2017-02-28
B46710032010100DIASOLDIASOL, INC.KPO2017-02-28
B46710032075100DIASOLDIASOL, INC.KPO2017-02-28
B46710032525100DIASOLDIASOL, INC.KPO2017-02-28
B46710033510100DIASOLDIASOL, INC.KPO2017-02-28
B46710033575100DIASOLDIASOL, INC.KPO2017-02-28
B46710042075100DIASOLDIASOL, INC.KPO2017-02-28
B467100422575100DIASOLDIASOL, INC.KPO2017-02-28
B46710043075100DIASOLDIASOL, INC.KPO2017-02-28
B46710043575100DIASOLDIASOL, INC.KPO2017-02-28
B4677811510200DIASOLDIASOL, INC.KPO2017-02-28
B4677812010200DIASOLDIASOL, INC.KPO2017-02-28
B4677821510200DIASOLDIASOL, INC.KPO2017-02-28
B4677822010200DIASOLDIASOL, INC.KPO2017-02-28