FDA.reportPublic FDA data

Renaflo II Hemofilter

Primary DI
00677964000089
Brand
Renaflo II Hemofilter
Company
MEDIVATORS INC.
Model
HF 1200
Catalog number
93024328
Device description
Renaflo II Hemofilter HF 1200
Published
2019-02-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30677964000080PackageGS112Not in Commercial Distribution
00677964000089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3067796400008030677964000080
00677964000089006779640000896779640000890677964000089

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 Temperature20 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)444-4729custserv@MEDIVATORS.com

Regulatory Flags#

DUNS number
068199363
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00677964154140Endo Carry-on Procedure Kit401156540115652026-10-28
00677964154157Endo Carry-on Procedure Kit401156740115672026-10-28
00677964154164Endo Carry-on Procedure Kit401157740115772026-10-28
00677964154171Endo Carry-on Procedure Kit401157840115782026-10-28
00677964154188Endo Carry-on Procedure Kit401169040116902026-10-28
00677964154195Endo Carry-on Procedure Kit401168040116802026-10-28
00677964154201Endo Carry-on Procedure Kit401168240116822026-10-28
00677964154218Endo Carry-on Procedure Kit401168340116832026-10-28
00677964154225Endo Carry-on Procedure Kit401168440116842026-10-28
00677964154232Endo Carry-on Procedure Kit401168540116852026-10-28
00677964154249Endo Carry-on Procedure Kit401168640116862026-10-28
00677964154256Endo Carry-on Procedure Kit401158140115812026-10-28
00677964154263Endo Carry-on Procedure Kit401168140116812026-10-28
00677964154270Endo Carry-on Procedure Kit401169640116962026-10-28
00677964154287Endo Carry-on Procedure Kit401169740116972026-10-28
00677964154294Endo Carry-on Procedure Kit401170240117022026-10-28
00677964154300Endo Carry-on Procedure Kit401170140117012026-10-28
00677964154317Endo Carry-on Procedure Kit401171240117122026-10-28
00677964154324Endo Carry-on Procedure Kit401171340117132026-10-28

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