FDA.reportPublic FDA data

Monoject

Primary DI
10192253007725
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
460SE
Catalog number
460SE
Device description
60 mL Enteral SyringeFor use with ENFit Connection System
Published
2026-02-19
Public version status
New
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
PNREnteral Syringes with enteral specific connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNREnteral Syringes With Enteral Specific ConnectorsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20192253007722PackageGS130In Commercial Distribution
50192253007723PackageGS14In Commercial Distribution
10192253007725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225300772220192253007722
5019225300772350192253007723
1019225300772510192253007725

GMDN Terms#

Term, Definition table
TermDefinition
ENFit oral/enteral syringe, single-useA manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume60Milliliter

Regulatory Flags#

DUNS number
961027315
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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008929NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008943NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008967NEOMED* At Home Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770008981NEOMED* At Home Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770009001NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770009018NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770009032NEOMED* Oral / Enteral Syringe with ENFit® ConnectorAvanos Medical, Inc.PNR2026-08-15
00350770009148NeoMedAvanos Medical, Inc.PNR2026-07-21
00827989008281Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2026-07-10
00827989008298Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2026-07-10
10192253007435MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007503MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007541MonojectCardinal Health 200, LLCPNR2026-02-19
10850053289672SurgycoSurgyco LLCPNR2025-12-11
10704411006169AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10704411007081AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10704411007104AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10827989004273Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-22
08015262020118NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262020132NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262035419NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262035488NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
08015262039301NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
10192253010923KangarooCardinal Health 200, LLCPNR2025-02-04
10827989000091Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
10827989000107Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08