FDA.reportPublic FDA data

5008X

Primary DI
00840861102884
Brand
5008X
Company
Fresenius Medical Care AG
Model
M204431
Device description
5008X + CDX
Published
2025-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2435050005008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC2025-05-30KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840861102884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840861102884008408611028848408611028840840861102884

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system, institutionalAn assembly of mains electricity (AC-powered) devices intended to be used to perform patient haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes, by trained professionals in a healthcare facility. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. It 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) 227-2572xx@xx.xx

Regulatory Flags#

DUNS number
324661834
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04039361261313DIASAFE®plusUSF00013010F000130102026-05-01
04039361259150FX CorALF000129692026-01-02
04039361259570FX CorALF000129702026-01-02
04039361259594FX CorALF000129712026-01-02
04039361259617FX CorALF000129732026-01-02
04039361259631FX CorALF000129742026-01-02
04039361259655FX CorALF000129752026-01-02
04039361259938FX CorALF000129722026-01-02
04039361259167FX CorALF000129692026-01-02
04039361259587FX CorALF000129702026-01-02
04039361259600FX CorALF000129712026-01-02
04039361259624FX CorALF000129732026-01-02
04039361259648FX CorALF000129742026-01-02
04039361259662FX CorALF000129752026-01-02
04039361259945FX CorALF000129722026-01-02
008408611028605008XM2044112025-08-01
008408611028775008XM2044212025-08-01
04039361207953Blood Pressure CuffF400166112025-08-01
04039361207960Blood Pressure CuffF400166102025-08-01
04039361208073Blood Pressure CuffF400166092025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414200183RevaclearVantive Health GmbHKDI2026-05-29
00842289103764EXPRESS FLUID WARMERNXSTAGE MEDICAL, INC.KDI2026-04-29
00842289103719VersiHDNXSTAGE MEDICAL, INC.KDI2026-04-22
08056992333543HPH-700 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333550HPH-700TS HEMOCONCENTRATMEDICA SPAKDI2026-04-01
08056992333567HPH-400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333574HPH-1000 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333581HPH-1400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333598HPH-400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333604HPH-1000TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333611HPH-1400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333628HPH JUNIORMEDICA SPAKDI2026-04-01
04039361259150FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259570FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259594FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259617FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259631FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259655FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259938FX CorALFresenius Medical Care AGKDI2026-01-02
00383790012379Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012386Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012393Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012409Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012416Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
04987671041708Hemodialysis Delivery SystemNIKKISO CO.,LTD.KDI2025-08-22
00860008016942Moda-flx Hemodialysis SystemDiality IncKDI2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncKDI2025-07-16
00383790011914Nipro Set Blood Tubing SetNIPRO MEDICAL CORPORATIONKDI2025-06-01
04987671030214Filter for dialysate purificationNIKKISO CO.,LTD.KDI2025-04-07
00850001011303TabloCart™ with Prefiltration DrawerOutset Medical, Inc.KDI2024-05-17