FDA.reportPublic FDA data

Acidified Concentrate Distribution and Storage (ACDS) System

Primary DI
00852456007092
Brand
Acidified Concentrate Distribution and Storage (ACDS) System
Company
Isopure, Corp.
Model
MD704262
Device description
Acidified Concentrate Distribution and Storage System (ACDS System)
Published
2017-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K120005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120005000ACDSIsopure, Corp.2012-03-29KPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852456007092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852456007092008524560070928524560070920852456007092

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system fluid mixerAn electrically-powered integral unit of a haemodialysis system that mixes a concentrate and water to the dialysis solution (dialysate) and monitors the mixture.

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
00852456007115Acid Dissolution SystemMD705102024-02-14
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

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