Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 30884521082926
• Version / Model: 8881540120
• Catalog Number: 8881540120
• 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: 7
• Public Version Date: 2019-12-11
• Public Version Status: Update
• Public Device Record Key: b3482f66-667d-42ae-9f3c-f4e3b6f1020f

Device Description

Blunt Tip Cannula,Vial Access Pin

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMI	Needle, hypodermic, single lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33963	Peripheral intravenous catheterization support kit	A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521082929	GS1	PACK_OR_INNER_PACK	100	In Commercial Distribution
Primary	30884521082926	GS1
Package	10884521082922	GS1	CASE	1000	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K980062	000

Storage Conditions

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