FDA.reportPublic FDA data

Monoject

Primary DI
20884521102528
Brand
Monoject
Company
Cardinal Health, Inc.
Model
460SG
Catalog number
460SG
Device description
Enteral Syringe with Tip Cap
Published
2018-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
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
20884521102528PackageGS1120In Commercial Distribution
30884521102525PackageGS130In Commercial Distribution
10884521102521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452110252820884521102528
3088452110252530884521102525
1088452110252110884521102521

GMDN Terms#

Term, Definition table
TermDefinition
Oral/enteral medicine medicated administration kit, single-useA collection of devices with an included pharmaceutical intended to be used for the oral and/or enteral administration of an accurate dosage of the included medication. In addition to the pharmaceutical, it will include a dose measuring and/or dispensing device(s) such as a calibrated syringe, medicine cup, or spoon, and may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume60Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884521174917Devon31141206311412062016-09-24
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24

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