Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 20192253051077
• Version / Model: 8881314440
• Catalog Number: 8881314440
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2024-02-28
• Public Version: 2
• Public Version Date: 2024-03-18
• Public Version Status: Update
• Public Device Record Key: 8e37420b-72f2-487f-9f60-9ff628e7cd9c

Device Description

Blood Collection Tube

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
GIM	Tubes, vacuum sample, with anticoagulant	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37563	Non-evacuated blood collection tube IVD, no additive	A non-evacuated glass or plastic tube, sealed with a stopper, containing no additive and intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50192253051078	GS1	CASE	10	In Commercial Distribution
Primary	20192253051077	GS1
Unit of Use	10192253051070	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius