Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 10884521012622
• Version / Model: 8881305117
• Catalog Number: 8881305117
• 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: 3
• Public Version Date: 2019-08-09
• Public Version Status: Update
• Public Device Record Key: 2965a1b0-2db5-4665-97bd-8161cffbb644

Device Description

Filter Needle

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAA	NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16266	Medication transfer needle, filtering	A slender, rigid, sharp or blunt tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication; it does not include a back-pressure venting feature. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521012629	GS1	CASE	1000	In Commercial Distribution
Primary	10884521012622	GS1
Unit of Use	30884521012626	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	1.50	Inch
Device Size Text, specify			Needle Gauge,18,Gauge;

Storage Conditions

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