FDA.reportPublic FDA data

Fresenius

Primary DI
04046241091731
Brand
Fresenius
Company
Fresenius Usa, Inc.
Model
M52840
Device description
JUG WAND, WHITE
Published
2015-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046241091731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046241091731040462410917314046241091731

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis dialysate tubing, single-useA sterile length of flexible tube, typically made of synthetic polymer material(s), intended to deliver haemodialysis dialysate and/or haemodialysis dialysate components (water, haemodialysis concentrate) to and/or from a haemodialysis machine/system. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2572xxx@xxx.xxx

Regulatory Flags#

DUNS number
076594100
Device count
1
Manufacturing date on label
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
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
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
07332414201340PRISMAFLEX SET M100Vantive Health GmbHKDI2026-03-27
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