FDA.reportPublic FDA data

2008® Series Hemodialysis Machines

Primary DI
00840861100965
Brand
2008® Series Hemodialysis Machines
Company
Fresenius Usa, Inc.
Model
190904
Device description
2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
Published
2015-09-24
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
ONWHemodialysis system for home use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONWHemodialysis System For Home UseGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K124035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1240350002008K@HOME HEMODIALYSIS MACHINEFresenius Medical Care North America2013-07-03ONW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840861100965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840861100965008408611009658408611009650840861100965

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system, institutional/home-useAn assembly of mains electricity (AC-powered) devices designed to perform haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. The system typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2572xxx@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
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
008408611009102008® Series Hemodialysis Machines1907662015-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840861100330CombiSetFresenius Medical Care Holdings, Inc.ONW2015-09-24
008408611009412008® Series Hemodialysis MachinesFresenius Usa, Inc.ONW2015-09-24
008408611009582008® Series Hemodialysis MachinesFresenius Usa, Inc.ONW2015-09-24
00840861101023WetAlert™ wireless wetness detectorFresenius Usa, Inc.ONW2015-09-24
10840861100337CombiSetFresenius Medical Care Holdings, Inc.ONW2015-09-24