FDA.reportPublic FDA data

EXALIS

Primary DI
07332414106126
Brand
EXALIS
Company
GAMBRO DASCO SPA
Model
113297
Catalog number
113297
Device description
Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data
Published
2018-11-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K083158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083158000EXALIS, SOFTWARE VERSION 1.15Gambro, Inc.2009-06-05KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332414106126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332414106126073324141061267332414106126

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information systemA dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. The system typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-0001MEDINFO_MEDPRODUCTS@BAXTER.COM

Regulatory Flags#

DUNS number
428788780
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414121594NA - NA1159591159592025-01-30
37332414121595NA - NA1159591159592025-01-30
07332414004699NA6431233B1013542016-10-28
07332414010867NA60380201015932016-10-28
07332414032531NA60324031020742016-10-28
07332414048914NA6432470A1057622016-05-06
07332414042035PHOENIX60230067001034532015-10-23
07332414075439NA60331121076202017-05-31
07332414044732NA60322051055512017-05-31
07332414075828NA60337651076502021-07-30
07332414106119EXALIS604190960419092018-11-14
37332414075829NA60337651076502021-07-30
37332414004690NA6431233B1013542016-10-28
37332414010868NA60380201015932016-10-28
37332414032532NA60324031020742016-10-28
37332414044733NA60322051055512017-05-31
37332414048915NA6432470A1057622016-05-06
37332414075430NA60331121076202017-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414200183RevaclearVantive Health GmbHKDI2026-05-29
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
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
00383790012379Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012386Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012393Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012409Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012416Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
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
00850001011303TabloCart™ with Prefiltration DrawerOutset Medical, Inc.KDI2024-05-17