Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 20884521010946
• Version / Model: 8881160157
• Catalog Number: 8881160157
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2021-02-23
• Public Version Status: Update
• Public Device Record Key: 834f1f44-1a48-411a-991d-cda2e412dfa9
• Distribution End Date: 2021-02-22

Device Description

60 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, piston	General Hospital	880.5860	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	10884521010949	GS1	CASE	100	Not in Commercial Distribution	2021-02-22
Primary	20884521010946	GS1
Unit of Use	30884521010943	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	60	Milliliter
Total Volume	12	Milliliter
Total Volume	140	Milliliter
Total Volume	3	Milliliter
Total Volume	18	Gallon
Total Volume	35	Milliliter
Total Volume	6	Milliliter
Total Volume	20	Milliliter

Storage Conditions

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