FDA.report

Monoject

Primary DI
50192253063392
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881906005
Catalog number
8881906005
Device description
6 mL Amber 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
OTC
false
Sterile
false
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
50192253063392PackageGS15In Commercial Distribution
20192253063391PrimaryGS10
10192253063394Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225306339250192253063392
2019225306339120192253063391
1019225306339410192253063394

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
100
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
true
Sterilization required before use
false

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10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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