Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 10884521750173
• Version / Model: 8881570121D
• Catalog Number: 8881570121D
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-26
• Public Version: 3
• Public Version Date: 2021-02-01
• Public Version Status: Update
• Public Device Record Key: 1b8ee1d2-1d36-41df-88f3-b45d867fe194
• Distribution End Date: 2021-02-01

Device Description

Monoject™ 0.9% Sodium Chloride Prefilled Flush Syringe, 10ML Fill, 12ML Syringe

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: No
• 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	30884521750177	GS1	CASE	6	Not in Commercial Distribution	2021-02-01
Package	20884521750170	GS1	Carton	30	Not in Commercial Distribution	2021-02-01
Primary	10884521750173	GS1

Storage Conditions

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