FDA.report

Monoject

Primary DI
20192253007432
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
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PNREnteral Syringes with enteral specific connectors

Product Code Classifications

CodeDeviceSpecialtyClass
PNREnteral Syringes With Enteral Specific ConnectorsGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20192253007432PackageGS160In Commercial Distribution
50192253007433PackageGS14In Commercial Distribution
10192253007435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225300743220192253007432
5019225300743350192253007433
1019225300743510192253007435

GMDN Terms

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

TypeValueUnit
Total Volume1Milliliter

Sterilization Methods

Method

Regulatory Flags

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

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
20192253007500MonojectCardinal Health 200, LLCPNR2026-02-19
50192253007549MonojectCardinal Health 200, LLCPNR2026-02-19
20192253007722MonojectCardinal Health 200, LLCPNR2026-02-19
20850053289679SurgycoSurgyco LLCPNR2025-12-11
00850016172051KBMEDKB Medical (group), Inc.PNR2025-05-21
00850016172716KBMEDKB Medical (group), Inc.PNR2025-05-21
00850016172792KBMEDKB Medical (group), Inc.PNR2025-05-21
00850016172808KBMEDKB Medical (group), Inc.PNR2025-05-21
00850016172730KBMEDKB Medical (group), Inc.PNR2025-05-21
00850016172785KBMEDKB Medical (group), Inc.PNR2025-05-21
30827989000224Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-30
30827989000231Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-30
30827989000248Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-30
30827989004277Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-22
10827989000152Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-10
10827989000169Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-10
10827989000176Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-10
10827989000183Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-10
10827989000190Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-10
10827989000206Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-10
10827989000213Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-10
10827989000220Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-10
10827989000237Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-10
10827989000244Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-10
10827989000251Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-10
20827989000258Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-10
18015262020115NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
18015262020139NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
18015262035416NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12
28015262035482NUTRIFITPENTAFERTE ITALIA SRLPNR2025-03-12