FDA.reportPublic FDA data

PRISMAFLEX SET

Primary DI
07332414064556
Brand
PRISMAFLEX SET
Company
GAMBRO INDUSTRIES
Model
M100
Catalog number
106697
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
2015-10-05
Public version status
Update
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
37332414064557PackageGS14In Commercial Distribution
07332414064556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241406455737332414064557
07332414064556073324140645567332414064556

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 Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
393020474
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
07332414064549PRISMAFLEX SETM601066962015-10-05
07332414069315PRISMAFLEX SETHF14001071422015-10-05
07332414090005PRISMAFLEX SETM1501099902015-10-05
07332414111038PRISMAFLEX TPE 2000 SET1140931140932017-03-23
07332414069254PRISMAFLEX SETHF10001071402015-10-05
07332414066314DIACLEAR1068871068872016-09-24
00085412917696PRISMAFLEX SET107640US107640US2022-11-22
00085412954073PRISMAFLEX SET107636US107636US2022-11-22
00085412954103PRISMAFLEX SET107643US107643US2022-11-22
50085412917691PRISMAFLEX SET107640US107640US2022-11-22
50085412954078PRISMAFLEX SET107636US107636US2022-11-22
50085412954108PRISMAFLEX SET107643US107643US2022-11-22
37332414064540PRISMAFLEX SETM601066962015-10-05
37332414064557PRISMAFLEX SETM1001066972015-10-05
37332414069316PRISMAFLEX SETHF14001071422015-10-05
37332414090006PRISMAFLEX SETM1501099902015-10-05
37332414069255PRISMAFLEX SETHF10001071402015-10-05
37332414066315DIACLEAR1068871068872016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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