Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 30884521005635
• Version / Model: 8881570300
• Catalog Number: 8881570300
• 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: 6
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: 57a4dcdb-cc87-4c24-b69d-38c0e835b8eb

Device Description

0.9% Sodium Chloride,Flush Syringe, 2.5 mL Fill

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
46309	Vascular catheter flush syringe	A sterile device consisting of a barrel (cylinder) with plunger intended to be used to wash the lumen of a vascular access catheter in situ with a rush of solution to maintain patency. It is prefilled with a saline or low-dose heparin solution, and is typically used when a patient has an intravenous (IV) access device in place. It is not intended for dry product reconstitution, for medication dilution, or where IV therapy with sodium chloride (NaCl) or heparin is indicated. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884521005631	GS1	PACK_OR_INNER_PACK	20	In Commercial Distribution
Primary	30884521005635	GS1
Package	20884521005638	GS1	CASE	180	In Commercial Distribution

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