FDA.reportPublic FDA data

Monoject

Primary DI
10192253007435
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
401SE
Catalog number
401SE
Device description
Enteral Syringe 1 mL Low Dose Tip (LDT) For 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
20192253007432PackageGS160In Commercial Distribution
50192253007433PackageGS14In Commercial Distribution
10192253007435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225300743220192253007432
5019225300743350192253007433
1019225300743510192253007435

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 Volume1Milliliter

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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770008998100mL ENFit GPro Syringe Purple SterileAvanos Medical, Inc.PNR2026-10-19
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
10192253007503MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007541MonojectCardinal Health 200, LLCPNR2026-02-19
10192253007725MonojectCardinal 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