Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 10884521015111
• Version / Model: 8881901014
• Catalog Number: 8881901014
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-06-27
• Public Version: 2
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: 97018ee8-d000-4bf9-bb59-88b3d2ae3a7d

Device Description

1 mL Oral Syringe,Clear

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYW	CONTAINER, LIQUID MEDICATION, GRADUATED	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45153	Oral medicine administration kit	A collection of devices intended to be used to assess the need for and/or to administer an accurate dosage of medication through oral intake. It will typically include a dose measuring and/or dispensing device such as a calibrated medicine cup, spoon or syringe, and the medication in an appropriate container, and may include a thermometer. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521015118	GS1	CASE	500	In Commercial Distribution
Primary	10884521015111	GS1
Unit of Use	30884521015115	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry;AVOID DIRECT SUNLIGHT