FDA.reportPublic FDA data

Revaclear

Primary DI
07332414200183
Brand
Revaclear
Company
Vantive Health GmbH
Model
Revaclear 500
Catalog number
955543A
Device description
REVACLEAR 500 dialyzer is indicated for the treatment of chronic or acute renal failure.
Published
2026-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K213639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213639000Revaclear 500, Revaclear 400, Revaclear 300Baxter Healthcare Corporation2022-01-24KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57332414200188PackageGS124In Commercial Distribution
00085412908397PreviousGS10
07332414200183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5733241420018857332414200188
00085412908397000854129083970854129083970085412908397
07332414200183073324142001837332414200183

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)284-4060US.customerservice@vantive.com

Regulatory Flags#

DUNS number
480723888
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414201340PRISMAFLEX SET M100106697MDR106697MDR2026-03-27
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
07332414201340PRISMAFLEX SET M100Vantive 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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00383790012416Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
04987671041708Hemodialysis Delivery SystemNIKKISO CO.,LTD.KDI2025-08-22
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00383790011914Nipro Set Blood Tubing SetNIPRO MEDICAL CORPORATIONKDI2025-06-01
04987671030214Filter for dialysate purificationNIKKISO CO.,LTD.KDI2025-04-07
00850001011303TabloCart™ with Prefiltration DrawerOutset Medical, Inc.KDI2024-05-17