FDA.reportPublic FDA data

PRISMAFLEX ST60 SET

Primary DI
07332414202422
Brand
PRISMAFLEX ST60 SET
Company
Vantive Health GmbH
Model
107643US
Catalog number
107643US
Device description
High Permeability Hemodialyzer
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
K212216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212216000Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation2022-04-01KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57332414202427PackageGS14In Commercial Distribution
00085412954103PreviousGS10
07332414202422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5733241420242757332414202427
00085412954103000854129541030854129541030085412954103
07332414202422073324142024227332414202422

GMDN Terms#

Term, Definition table
TermDefinition
HaemofilterA filter used in the process of haemofiltration, a treatment whereby extracorporeal blood is slowly and continuously passed through a system to allow for the removal of toxins and/or the replacement of electrolytes. The device functions with dialysate solution for the transfer of substances by diffusion and convection. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)553-6898Us.RENAL.Support.Co@vantive.com

Regulatory Flags#

DUNS number
480723888
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414202439PRISMAFLEX ST100 SET107636US107636US2026-10-23
07332414202446PRISMAFLEX ST150 SET107640US107640US2026-10-23
07332414124731TherMax9556309556302026-10-21
07332414126018Prismax9557249557242026-10-21
57332414206296Sharesource Connectivity Platform for Use with the Homechoice Claria APD System5CGM012026-09-22
07332414202491Homechoice Claria APD Cycler5C6M405C6M402026-08-27
07332414202309TherMax955516MDR955516MDR2026-07-06
07332414200183RevaclearRevaclear 500955543A2026-05-29
07332414201340PRISMAFLEX SET M100106697MDR106697MDR2026-03-27
07332414201364PRISMAFLEX SET M150109990MDR109990MDR2026-03-27
07332414201388PRISMAFLEX SET M60106696MDR106696MDR2026-03-27
07332414088316BiCart7201097332015-09-24
07332414110574BiCart12501140142015-09-24
07332414127213CLCA - CLEANCART A9558509558502023-12-01
07332414127220CLCC - CLEANCART C9558519558512023-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414202439PRISMAFLEX ST100 SETVantive Health GmbHKDI2026-10-23
07332414202446PRISMAFLEX ST150 SETVantive Health GmbHKDI2026-10-23
07332414124731TherMaxVantive Health GmbHKDI2026-10-21
07332414126018PrismaxVantive Health GmbHKDI2026-10-21
04039361273590multiFluxFresenius Medical Care Holdings, Inc.KDI2026-09-29
04039361273613multiFluxFresenius Medical Care Holdings, Inc.KDI2026-09-29
07332414202309TherMaxVantive Health GmbHKDI2026-07-06
08056992333536HEMOCOR HPH MINI - PEDIATRICMEDICA SPAKDI2026-07-06
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