Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 10884521000261
• Version / Model: 8881570121
• Catalog Number: 8881570121
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 9
• Public Version Date: 2022-02-11
• Public Version Status: Update
• Public Device Record Key: 7b94fe8a-15b3-44ef-9c8f-501e6c251854
• Distribution End Date: 2022-02-01

Device Description

True content to be populated as part of rebranding

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NGT	Saline, vascular access flush	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521000268	GS1	BOX	30	Not in Commercial Distribution	2022-02-01
Primary	10884521000261	GS1
Package	30884521000265	GS1	CASE	6	Not in Commercial Distribution	2022-02-01

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius