Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 40884521005694
• Version / Model: 8881571300
• Catalog Number: 8881571300
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: f57648bd-78ba-42e5-97e3-e7e75d1d8b99

Device Description

0.9% Sodium Chloride,Flush Syringe, 2.5 mL Fill, Blunt Cannula

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
NGT	Saline, vascular access flush	General Hospital	880.5200	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	20884521005690	GS1	CASE	180	In Commercial Distribution
Primary	40884521005694	GS1
Unit of Use	50884521005691	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K032438	000

Device Sizes

Type	Value	Unit	Text
Total Volume	2.5	Milliliter

Storage Conditions

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