FDA.reportPublic FDA data

EXACTAMIX

Primary DI
00085412475813
Brand
EXACTAMIX
Company
BAXTER HEALTHCARE CORPORATION
Model
H938176
Catalog number
H938176
Device description
EXACTAMIX Inlet, Syringe Inlet
Published
2016-09-23
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
LHISet, i.V. Fluid transfer
NEPSYSTEM/DEVICE, PHARMACY COMPOUNDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2
NEPSystem/Device, Pharmacy CompoundingGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002705000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002705000EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400Baxa Corp.2001-03-28LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412475818PackageGS125In Commercial Distribution
00085412475813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541247581850085412475818
00085412475813000854124758130854124758130085412475813

GMDN Terms#

Term, Definition table
TermDefinition
Compounding transfer setA collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
005083209
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412478296BaxterH93813501H938135012026-05-29
00085412478302BaxterH93813601H938136012026-05-29
00085412004945INTERLINK2N33792N33792016-09-24
00085412004983INTERLINK2N33992N33992016-09-24
00085412048895CLEARLINK2N83992N83992016-09-24
00085412002125INTERLINK2C64022C64022016-09-24
00085412003948INTERLINK/DUO-VENT2C64192C64192016-09-24
00085412017716INTERLINK/CONTINU-FLO3C00623C00622016-09-24
00085412046389CLEARLINK/DUO-VENT2C88752C88752016-09-24
00085412048499CLEARLINK/DUO-VENT2H84802H84802016-09-24
00085412048932CLEARLINK2C84012C84012016-09-24
00085412048949CLEARLINK2C84022C84022016-09-24
00085412048987CLEARLINK/CONTINU-FLO2C85462C85462016-09-24
00085412048994CLEARLINK/CONTINU-FLO2C85192C85192016-09-24
00085412049090CLEARLINK2H84012H84012016-09-24
00085412051703CLEARLINK/CONTINU-FLO2C85152C85152016-09-24
00085412068190INTERLINK2H64012H64012016-09-24
00085412069302CLEARLINK/CONTINU-FLO/CONTROL-A-FLO2C88952C88952016-09-24
00085412071107CLEARLINK/CONTINU-FLO/DUO-VENT2C85412C85412016-09-24
00085412071190CLEARLINK2C84252C84252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00887709098602ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-05-28
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08699443581911FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443581928FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585292FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585308FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585315FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585322FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585339FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
10815879021929IV PlusNEXUS MEDICAL, LLCLHI2025-10-03
10815879021806 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-10-21
08699443580174FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-10-07
10815879021783IV PlusNEXUS MEDICAL, LLCLHI2024-09-27
10815879021745IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
10815879021752IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
08699443580167FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-08-05
10815879021677 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-04-02
10197344001699MedlineMEDLINE INDUSTRIES, INC.LHI2024-03-05
10815879021660IV PlusNEXUS MEDICAL, LLCLHI2024-03-05
10860009080505NavaClick Injection KitLineage Biomedical, Inc.LHI2024-01-30
10815879021547IV PlusNEXUS MEDICAL, LLCLHI2022-09-08
10193489896848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LHI2022-08-04
10815879021523IV PlusNEXUS MEDICAL, LLCLHI2022-06-15
10612479261959McKessonMCKESSON MEDICAL-SURGICAL INC.LHI2022-02-24
10612479261973McKessonMCKESSON MEDICAL-SURGICAL INC.LHI2022-02-24
08426314391399GRI-BAGLABORATORIOS GRIFOLS SANEP2021-10-26
08426314391412GRI-BAGLABORATORIOS GRIFOLS SANEP2021-10-26
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