FDA.reportPublic FDA data

Monoject

Primary DI
20192253010951
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881901006
Catalog number
8881901006
Device description
1 mL Amber Oral Syringe
Published
2022-04-18
Public version status
Update
Distribution status
Not 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
50192253010952PackageGS15Not in Commercial Distribution
20192253010951PrimaryGS10
10192253010954Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225301095250192253010952
2019225301095120192253010951
1019225301095410192253010954

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
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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