FDA.reportPublic FDA data

DIASOL

Primary DI
B46710010075200
Brand
DIASOL
Company
DIASOL, INC.
Model
100100-75200
Catalog number
ACG6
Device description
Diasol Liquid Acid Concentrate for Bicarbonate Dialysis
Published
2017-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K851431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851431000HEMODIALYSIS CONCENTRATE ADDITIVESDana Laboratories1985-06-12KPO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B467100100752004PackageHIBCC4In Commercial Distribution
B4671001007520055PackageHIBCC1In Commercial Distribution
B46710010075200PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep from freezing and excessive heat.

Contacts#

Phone, Email table
PhoneEmail
818-838-7077Diasolinc@gmail.com

Regulatory Flags#

DUNS number
068434658
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
B46710000075100DIASOL100000-75100ACD15-ACG302017-02-13
B46710000075200DIASOL100000-75200ACG12017-02-13
B46710001575100DIASOL100015-75100ACG312017-02-24
B46710001575200DIASOL100015-75200ACG22017-02-13
B46710002075100DIASOL100020-75100ACG322017-02-24
B46710002075200DIASOL100020-75200ACG32017-02-14
B467100022510100DIASOL1000225-10100ACG332017-02-13
B467100022575100DIASOL1000225-75100ACG342017-02-24
B467100022575200DIASOL1000225-75200ACG42017-02-13
B46710002575100DIASOL100025-75100ACG352017-02-14
B46710002575200DIASOL100025-75200ACG52017-02-13
B46710003510100DIASOL100035-10100ACG362017-02-24
B46710010010100DIASOL100100-10100ACG372017-02-24
B46710010075100DIASOL100100-75100ACG382017-02-24
B46710011010100DIASOL100110-10100ACG392017-02-24
B46710011575100DIASOL100115-75100ACG402017-02-24
B46710012010100DIASOL100120-10100ACGG412017-02-14
B46710012075100DIASOL100120-75100ACD16-ACG422017-02-14
B46710012075200DIASOL100120-75200ACD1-ACG72017-02-07
B467100122575100DIASOL1001225-75100ACD172017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842289103245NxStage PureFlow SolutionNXSTAGE MEDICAL, INC.KPO2026-06-22
00842289103252NxStage PureFlow SolutionNXSTAGE MEDICAL, INC.KPO2026-06-22
00842289103269NxStage PureFlow SolutionNXSTAGE MEDICAL, INC.KPO2026-06-22
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