FDA.reportPublic FDA data

EXACTAMIX

Primary DI
00085412477305
Brand
EXACTAMIX
Company
BAXTER HEALTHCARE CORPORATION
Model
H938792
Catalog number
H938792
Device description
EXACTAMIX 1200 Valve Set
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
50085412477300PackageGS110In Commercial Distribution
00085412477305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541247730050085412477300
00085412477305000854124773050854124773050085412477305

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
00085412004747INTERLINK2N33392N33392016-09-24
00085412004785INTERLINK2N33432N33432016-09-24
00085412004792MICRO-VOLUME2N33452N33452016-09-24
00085412004808Baxter2N33462N33462016-09-24
00085412004815Micro-Volume2N33472N33472016-09-24
00085412004839Baxter2N33492N33492016-09-24
00085412036373INTERLINK2C75572C75572016-09-24
00085412036380INTERLINK2C75582C75582016-09-24
00085412046372CLEARLINK2C88572C88572016-09-24
00085412071688CLEARLINK2C88582C88582016-09-24
00085412003252Aviva/Viaflex2B80662B80662016-09-24
00085412036311Baxter2C62502C62502016-09-24
00085412600024DUPLOCATH150616515061652018-09-28
00085412600031DUPLOCATH150616615061662018-09-28
00085412600048DUPLOCATH150616715061672018-09-28
00085412002576INTERLINK2C74512C74512016-09-24
00085412002583INTERLINK/DUO-VENT2C74522C74522016-09-24
00085412004976INTERLINK2N33952N33952016-09-24
00085412046334CLEARLINK2C86712C86712016-09-24
00085412046433CLEARLINK2H86032H86032016-09-24

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Primary DI, Brand, Company table
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18859299138326ADRx Admixture SystemEPIC INTERNATIONAL(THAILAND) COMPANY LIMITEDLHI2026-08-01
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10813153027384CodanCodan US CorporationLHI2026-06-25
00887709126503ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-06-24
00887709170995ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-06-02
00887709098602ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-05-28
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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
04063574200371nextaro® va 15, 5 µm Filtersfm medical devices GmbHLHI2024-09-11
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04063574200357nextaro® 20/32, vented, 15 µm nominal Filtersfm medical devices GmbHLHI2024-06-05
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