FDA.reportPublic FDA data

Dry Acid Dissolution Unit

Primary DI
00840861100996
Brand
Dry Acid Dissolution Unit
Company
Fresenius Usa, Inc.
Model
160147
Device description
132 Gallon
Published
2015-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00840861100996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840861100996008408611009968408611009960840861100996

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-5188xxx@xxx.xxx

Regulatory Flags#

DUNS number
076594100
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840861102280VersiPD1308312023-08-01
008408611009652008® Series Hemodialysis Machines1909042015-09-24
00840861102198VersiPD1308212023-02-14
00840861102297VersiPD1308322023-02-14
008408611008972008® Series Hemodialysis Machines1907132015-09-30
008408611009032008® Series Hemodialysis Machines1908582015-09-30
008408611009342008® Series Hemodialysis Machines1909082016-06-06
008408611009412008® Series Hemodialysis Machines1908282015-09-24
04046241091694FreseniusM528372015-10-02
04046241091700FreseniusM528362015-10-02
04046241091717FreseniusM528382015-10-02
04046241091731FreseniusM528402015-10-02
00840861102020Crit-Line®1910581910582016-10-04
00840861101023WetAlert™ wireless wetness detector1905072015-09-24
10840861102027Crit-Line®1910581910582016-10-04
00840861100552Crit-Line®CL10041021CL100410212015-10-19
10840861100559Crit-Line®CL10041021CL100410212015-10-19
008408611008592008® Series Hemodialysis Machines1906102015-09-30
008408611008662008® Series Hemodialysis Machines1906302015-09-30
008408611008732008® Series Hemodialysis Machines1906332015-09-30

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