Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 10884521010802
• Version / Model: 1182000777
• Catalog Number: 1182000777
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: efc6de75-949a-4aef-8e04-90158d4ccdaf

Device Description

20 mL Syringe,Luer-Lock Tip

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
35904	Metered-delivery hypodermic syringe	A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521010809	GS1	PACK_OR_INNER_PACK	40	In Commercial Distribution
Primary	10884521010802	GS1
Package	30884521010806	GS1	CASE	160	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	20	Milliliter

Storage Conditions

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