FDA.reportPublic FDA data

HPH-700 HEMOCONCENTRATOR

Primary DI
08056992333543
Brand
HPH-700 HEMOCONCENTRATOR
Company
MEDICA SPA
Model
02
Catalog number
93024-117
Device description
HPH-700 HEMOCONCENTRATOR
Published
2026-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K983085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983085000HEMOCOR HPH 700 HEMOCONCENTRATORMinntech Corp.1998-11-13KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056992333543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056992333543080569923335438056992333543

GMDN Terms#

Term, Definition table
TermDefinition
HaemoconcentratorA sterile filter intended to be used in the process of haemoconcentration (the concentration of blood elements by water and electrolyte removal) typically during treatment for fluid overload or during cardiac surgery involving extracorporeal circulation. It is typically an ultrafiltration filter contained within a closed cylindrical housing with connectors to an extracorporeal blood circuit and separate connectors for the removal of excess plasma water together with small plasma solutes (e.g., smaller than 50,000 Daltons); the haemoconcentrate is returned to the patient. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
435402151
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056992333550HPH-700TS HEMOCONCENTRAT0293024-1182026-04-01
08056992333567HPH-400 HEMOCONCENTRATOR0193024-1202026-04-01
08056992333574HPH-1000 HEMOCONCENTRATOR0293024-1212026-04-01
08056992333581HPH-1400 HEMOCONCENTRATOR0193024-1222026-04-01
08056992333598HPH-400TS HEMOCONCENTRATOR0493024-1232026-04-01
08056992333604HPH-1000TS HEMOCONCENTRATOR0493024-1242026-04-01
08056992333611HPH-1400TS HEMOCONCENTRATOR0493024-1252026-04-01
08056992333628HPH JUNIOR0493024-2562026-04-01

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
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
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
04987671030214Filter for dialysate purificationNIKKISO CO.,LTD.KDI2025-04-07