Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 10884521551374
• Version / Model: 400BE
• Catalog Number: 400BE
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2017-07-03
• Public Version: 9
• Public Version Date: 2023-07-03
• Public Version Status: Update
• Public Device Record Key: 8021bbc0-3056-460a-aa8a-998244dfd6b6
• Distribution End Date: 2023-07-01

Device Description

Enteral Syringe Cap

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PNR	Enteral Syringes with enteral specific connectors	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16825	Syringe tip cap	A device intended to cover the tip of a syringe (without a needle) in order to prevent the leakage of syringe contents and to maintain content sterility until the syringe is used. This device is typically constructed of plastic. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521551371	GS1	CASE	1000	Not in Commercial Distribution	2023-07-01
Primary	10884521551374	GS1
Unit of Use	30884521551378	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: No