Monoject

Basic Information

• Brand Name: Monoject
• Primary DI: 20192253050902
• Version / Model: 1270016000
• Catalog Number: 1270016000
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2025-01-28
• Public Version: 1
• Public Version Date: 2025-02-05
• Public Version Status: New
• Public Device Record Key: 09a1b72d-b5dd-4ed3-9e97-1049837b0192

Device Description

Sample Cup for 16 mm Tubes

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JKA	Tubes, vials, systems, serum separators, blood collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62229	Test tube/reservoir cap	A covering intended to be used to seal the top of a test tube or reagent reservoir to protect the contents against contamination from the external environment, and to prevent spillage and/or evaporation of contents during transportation or processing. The top of the cap may be penetrable to enable injection or aspiration of contents. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50192253050903	GS1	CASE	5	In Commercial Distribution
Primary	20192253050902	GS1
Unit of Use	10192253050905	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	2	Milliliter