FDA.reportPublic FDA data

PRISMAFLEX SET M100

Primary DI
07332414201340
Brand
PRISMAFLEX SET M100
Company
Vantive Health GmbH
Model
106697MDR
Catalog number
106697MDR
Device description
The Prismaflex M100 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K041005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041005000GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETSGambro Renal Products2004-10-07KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57332414201345PackageGS14In Commercial Distribution
07332414201340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5733241420134557332414201345
07332414201340073324142013407332414201340

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height9Centimeter
Length27Centimeter
Weight814Gram
Width22Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the Prismaflex set in a dry place, between 0° C (32° F) and 30° C (86° F).

Contacts#

Phone, Email table
PhoneEmail
+1(800)240-4060US.customerservice@vantive.com

Regulatory Flags#

DUNS number
480723888
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
07332414201364PRISMAFLEX SET M150Vantive Health GmbHKDI2026-03-27
07332414201388PRISMAFLEX SET M60Vantive 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
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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
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