FDA.reportPublic FDA data

Monoject

Primary DI
20192253063384
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881901014
Catalog number
8881901014
Device description
1 mL Clear Oral Syringe
Published
2023-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYWCONTAINER, LIQUID MEDICATION, GRADUATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYWContainer, Liquid Medication, GraduatedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253063385PackageGS15In Commercial Distribution
20192253063384PrimaryGS10
10192253063387Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225306338550192253063385
2019225306338420192253063384
1019225306338710192253063387

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.

Regulatory Flags#

DUNS number
961027315
Device count
100
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008021Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-03-24
00827989008038Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-03-24
00827989008045Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-03-24
00827989008052Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-03-24
00827989007901Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
00827989007918Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
00827989007925Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
00827989007932Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007907Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007914Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007921Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007938Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
30815112021444Mixing ContainerBracco Diagnostics Inc.KYW2026-01-09
16931918145068AllesetGRI Medical & Electronic Technology Co., Ltd.KYW2025-06-20
00661392002180LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
00661392012332LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
00840306835988Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2025-01-16
00840306836008Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2025-01-16
10827989003467Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
10827989003474Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
10827989003481Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
10827989003498Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
00616784425238Medicine Cups 1oz Dynarex CorporationKYW2024-10-28
00810180844918Medicine Cups 1oz Dynarex CorporationKYW2024-10-28
10653160381464MEDLINEMEDLINE INDUSTRIES, INC.KYW2024-10-18
16931918172811AllesetGRI Medical & Electronic Technology Co., Ltd.KYW2024-09-05
00852359007403CrushieldMAXPERT MEDICALKYW2024-05-13
10827989002095Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2024-04-16
10827989002101Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2024-04-16
10827989002118Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2024-04-16