FDA.reportPublic FDA data

Monoject

Primary DI
20192253003359
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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. It is also intended to be used as a heparin lock by keeping the heparin flush solution in the catheter. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884450807136High Pressure Tubing, Keep™Merit Medical Systems, Inc.FPK2025-11-25
20884450859586Pressure Monitor TubingMerit Medical Systems, Inc.FPK2025-09-05
10884450815400High Pressure TubingMerit Medical Systems, Inc.FPK2025-07-23
10884450569235Merit Medical®Merit Medical Systems, Inc.FPK2025-06-19
10884450859619Pressure Monitor TubingMerit Medical Systems, Inc.FPK2025-05-13
10884450859657Pressure Monitor TubingMerit Medical Systems, Inc.FPK2025-05-13
10884450859671Pressure Monitor TubingMerit Medical Systems, Inc.FPK2025-05-13
20884450569218Merit Medical®Merit Medical Systems, Inc.FPK2025-04-21
20884450833340Merit Medical®Merit Medical Systems, Inc.FPK2025-04-21
20884450859609Pressure Monitor TubingMerit Medical Systems, Inc.FPK2025-04-21
10884450859565High Pressure TubingMerit Medical Systems, Inc.FPK2025-03-15
20884450859593Pressure Monitor TubingMerit Medical Systems, Inc.FPK2025-02-26
10884450859893High Pressure TubingMerit Medical Systems, Inc.FPK2025-01-28
20884450859883High Pressure TubingMerit Medical Systems, Inc.FPK2025-01-22
20884450628304Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2024-12-07
20884450821262High Pressure Tubing, Keep™Merit Medical Systems, Inc.FPK2024-11-01
20884450569379Pressure Monitor TubingMerit Medical Systems, Inc.FPK2024-10-18
50192253003336MonojectCardinal Health 200, LLCFPK2024-08-21
50192253003343MonojectCardinal Health 200, LLCFPK2024-08-21
20884450807112High Pressure Tubing, Keep™Merit Medical Systems, Inc.FPK2024-07-20
10884450807108High Pressure TubingMerit Medical Systems, Inc.FPK2024-07-18
10884450821258High Pressure TubingMerit Medical Systems, Inc.FPK2024-07-12
20884450821224High Pressure TubingMerit Medical Systems, Inc.FPK2024-07-02
10884450821234High Pressure TubingMerit Medical Systems, Inc.FPK2024-06-26
20884450815322High Pressure TubingMerit Medical Systems, Inc.FPK2024-06-12
40616258024552Swabbable Valve Transfer SetBayer Medical Care Inc.FPK2024-05-06
40616258024569MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
40616258024828MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
10884450807122High Pressure TubingMerit Medical Systems, Inc.FPK2024-03-12
10884450569365Pressure Monitor TubingMerit Medical Systems, Inc.FPK2023-11-14