FDA.reportPublic FDA data

EXACTAMED

Primary DI
00085412476575
Brand
EXACTAMED
Company
Baxter Healthcare SA
Model
H93847
Catalog number
H93847
Device description
Dispensing Pin
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
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
50085412476570PackageGS150In Commercial Distribution
00085412476575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541247657050085412476570
00085412476575000854124765750854124765750085412476575

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
481009905
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
00085412680743SOLUTION SET2C04272C04272020-09-16
00085412030531NAR5C4479R5C44792025-08-28
50085412030536NAR5C4479R5C44792025-08-28
05413760476216Tisseel/Artiss Spray Set150427215042722016-09-24
05413760476223Tisseel/Artiss Spray Set150427315042732016-09-24
00085412087788Coseal Spray Set060002106000212017-03-23
00085412169286DUO-VENT2C04272C04272025-03-20
50085412169281DUO-VENT2C04272C04272025-03-20
00085412908397RevaclearRevaclear 500955543A2024-04-12
00085412908427RevaclearRevaclear 400114746A2024-04-12
00085412908434RevaclearRevaclear 300114745A2024-04-12
50085412908392RevaclearRevaclear 500955543A2024-04-12
50085412908422RevaclearRevaclear 400114746A2024-04-12
50085412908439RevaclearRevaclear 300114745A2024-04-12

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