FDA.reportPublic FDA data

EXACTAMIX

Primary DI
00085412476827
Brand
EXACTAMIX
Company
BAXTER HEALTHCARE CORPORATION
Model
H93884
Catalog number
H93884
Device description
Luer Lock-to-Bag Adapter
Published
2016-09-24
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
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872743000BAXA TUBING SETS (FOR PHARMACY PUMP)Baxa Corp., Sub. of Cook Group, Inc.1987-10-09FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412476822PackageGS150In Commercial Distribution
00085412476827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541247682250085412476822
00085412476827000854124768270854124768270085412476827

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. 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
00085412000046INTRAVIA2B80142B80142016-09-24
00085412003191INTRAVIA2B80122B80122016-09-24
00085412003467INTRAVIA2B80112B80112016-09-24
00085412003504INTRAVIA2B80192B80192016-09-24
00085412029566INTRAVIA2J80032J80032016-09-24
00085412029573INTRAVIA2J80022J80022016-09-24
00085412035260INTRAVIA2B80132B80132016-09-24
00085412048475CLEARLINK/DUO-VENT2C74622C74622016-09-24
00085412079677CLEARLINK/CONTINU-FLOACT8570ACT85702016-09-24
00085412046327CLEARLINK/CONTINU-FLO2C85712C85712016-09-24
00085412048451CLEARLINK/CONTINU-FLO2H85192H85192016-09-24
00085412080901CLEARLINK/CONTINU-FLO2H85372H85372016-09-24
00085412676630DUO-VENT2R84042R84042023-07-11
00085412478296BaxterH93813501H938135012026-05-29
00085412478302BaxterH93813601H938136012026-05-29
00085412004945INTERLINK2N33792N33792016-09-24
00085412004983INTERLINK2N33992N33992016-09-24
00085412048895CLEARLINK2N83992N83992016-09-24
00085412002125INTERLINK2C64022C64022016-09-24
00085412003948INTERLINK/DUO-VENT2C64192C64192016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530754033Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754057Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754118Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754149polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754170polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754255polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754279polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754286polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754323polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754385polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754415polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754477polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754484polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754651polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754736polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
10192253070804MonojectCardinal Health 200, LLCFMF2026-09-21
M992MTINS01291271MedThermalCarelife (usa) Inc.FMF2026-09-18
M992MTINS0331081MedThermalCarelife (usa) Inc.FMF2026-09-18
00850091070242CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070372CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070389CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070396CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070402CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070419CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
06976523540238Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540252Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14