FDA.reportPublic FDA data

POLYFLUX REVACLEAR MAX

Primary DI
07332414101701
Brand
POLYFLUX REVACLEAR MAX
Company
GAMBRO RENAL PRODUCTS, INC.
Model
110634
Catalog number
110634
Device description
Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis
Published
2015-10-07
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414101702PackageGS124Not in Commercial Distribution
07332414101701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241410170237332414101702
07332414101701073324141017017332414101701

GMDN Terms#

Term, Definition table
TermDefinition
Hollow-fibre haemodialysis dialyser, single-useA filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
929768682
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414123055REVACLEAR300114745L2017-02-08
07332414124076REVACLEAR400114746L2018-01-15
07332414101695POLYFLUX REVACLEAR1106331106332015-10-07
37332414101696POLYFLUX REVACLEAR1106331106332015-10-07
37332414101702POLYFLUX REVACLEAR MAX1106341106342015-10-07
37332414123056REVACLEAR300114745L2017-02-08
37332414124077REVACLEAR400114746L2018-01-15

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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
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04039361259938FX CorALFresenius Medical Care AGKDI2026-01-02
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