Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 10192253068856
• Version / Model: 1183500888
• Catalog Number: 1183500888
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-29
• Public Version: 1
• Public Version Date: 2026-02-06
• Public Version Status: New
• Public Device Record Key: 3ad55d04-22c3-43b0-b89d-4bfd8d5da9ef

Device Description

35 mL Syringe Catheter Tip

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYZ	SYRINGE, IRRIGATING (NON DENTAL)	General Hospital	880.6960	1

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	50192253068854	GS1	CASE	4	In Commercial Distribution
Package	20192253068853	GS1	BOX	40	In Commercial Distribution
Primary	10192253068856	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	35	Milliliter