FDA.reportPublic FDA data

Monoject

Primary DI
10192253003352
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8888115006
Catalog number
8888115006
Device description
Intermittent Infusion Plug Standard
Published
2024-08-21
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

Product Codes#

Code, Name table
CodeName
FPKTubing, fluid delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPKTubing, Fluid DeliveryGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20192253003359PackageGS150In Commercial Distribution
50192253003350PackageGS15In Commercial Distribution
10192253003352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225300335920192253003359
5019225300335050192253003350
1019225300335210192253003352

GMDN Terms#

Term, Definition table
TermDefinition
Catheter injection portA device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. Some types may be designed as a Y-connector with an additional inlet (e.g., with a female Luer connection point) to facilitate sequential injection and infusion of fluids (e.g., medication followed by saline). It may be additionally intended for use as a heparin/saline lock by keeping the flush solution in the catheter. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450628307Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2024-12-07
10192253003338MonojectCardinal Health 200, LLCFPK2024-08-21
10192253003345MonojectCardinal Health 200, LLCFPK2024-08-21
00616258024554Swabbable Valve Transfer SetBayer Medical Care Inc.FPK2024-05-06
00616258024561MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
00616258024820MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
10884450325312Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2021-04-05
10849884002260VYGONVygon CorporationFPK2020-06-02
00849884002720VYGONVygon CorporationFPK2020-06-01
0063462495724425ft/7.6m IV Extension SetQUEST MEDICAL INCFPK2020-04-13
10849884002666VYGONVygon CorporationFPK2020-04-02
10849884002765VYGONVygon CorporationFPK2020-04-02
10849884002581VYGONVygon CorporationFPK2020-04-01
00849884004441VYGONVygon CorporationFPK2020-03-12
00849884003956VYGONVygon CorporationFPK2020-01-28
00849884004007VYGONVygon CorporationFPK2020-01-28
10351688507112MedexICU MEDICAL, INC.FPK2020-01-13
00849884000320VYGONVygon CorporationFPK2019-12-16
00849884000559VYGONVygon CorporationFPK2019-12-16
00849884000566VYGONVygon CorporationFPK2019-12-16
00634624957817Exoflex 10.5in. IVExtension SetQUEST MEDICAL INCFPK2019-12-09
00634624957879Exoflex 14.5in. IVExtension SetQUEST MEDICAL INCFPK2019-12-09
00849884000269VYGONVygon CorporationFPK2019-11-14
00849884000313VYGONVygon CorporationFPK2019-11-14
00849884000375VYGONVygon CorporationFPK2019-11-14
00849884000443VYGONVygon CorporationFPK2019-11-14
00849884000450VYGONVygon CorporationFPK2019-11-14
00849884000467VYGONVygon CorporationFPK2019-11-14
00849884000535VYGONVygon CorporationFPK2019-11-14
00849884001464VYGONVygon CorporationFPK2019-11-01