Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 20192253051183
• Version / Model: 8881301859
• Catalog Number: 8881301859
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2024-10-08
• Public Version: 3
• Public Version Date: 2025-03-31
• Public Version Status: Update
• Public Device Record Key: b7d082ba-e0b4-4956-ac6f-3a3bcd8a4a0a
• Distribution End Date: 2025-03-31

Device Description

Blood Collection Tube, Silicone Coated Tube, Silicone Coated Red Stopper, No Additive, 15 mL Draw, 16 x 125 mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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	50192253051184	GS1	CASE	10	Not in Commercial Distribution	2025-03-31
Primary	20192253051183	GS1
Unit of Use	10192253051186	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius