FDA.report

Monoject

Primary DI
20884521140957
Brand
Monoject
Company
Cardinal Health, Inc.
Model
412SG
Catalog number
412SG
Device description
Enteral Syringe with Tip Cap
Published
2018-06-27
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

Related Records

Product Codes

CodeName
KYWCONTAINER, LIQUID MEDICATION, GRADUATED

Product Code Classifications

CodeDeviceSpecialtyClass
KYWContainer, Liquid Medication, GraduatedGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884521140957PackageGS148In Commercial Distribution
30884521140954PackageGS1192In Commercial Distribution
10884521140950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088452114095720884521140957
3088452114095430884521140954
1088452114095010884521140950

GMDN Terms

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

TypeValueUnit
Total Volume12Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods

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 DIBrandModelCatalogPublished
10884527009954Kendall30781747307817472018-06-23
30884527004748Kendall5000736150007361-2016-09-24
10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

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80827989007938Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
30815112021444Mixing ContainerBracco Diagnostics Inc.KYW2026-01-09
00194613039127MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-08-01
00194613046330MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-08-01
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00194613121082MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-08-01
06931918145061AllesetGRI Medical & Electronic Technology Co., Ltd.KYW2025-06-20
10661392002187LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
10661392012339LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
00194613096519MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-03-21
00194613122669MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-03-21
10827989000268Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-03-13
10827989003627Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-03-13
20827989003464Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
20827989003471Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
20827989003488Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
20827989003495Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
00840306835964Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-12-11
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00840306836015Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-10-22
00653160381467MEDLINEMEDLINE INDUSTRIES, INC.KYW2024-10-18
00840216128033ASP MEDICALAsp Global, LLCKYW2024-09-12