Covidien

Basic Information

• Brand Name: Covidien
• Primary DI: 50192253051214
• Version / Model: 8881389459
• Catalog Number: 8881389459
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 400
• Record Status: Published
• Publish Date: 2025-01-14
• Public Version: 3
• Public Version Date: 2025-03-31
• Public Version Status: Update
• Public Device Record Key: 7e77900d-270c-4f2c-a80d-fdfd4e4acbb3
• Distribution End Date: 2025-03-31

Device Description

Isolator 10 mL Tubes, 50C7 Product, 16 x 100 mm, Abbott Diagnostics

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
43651	General specimen receptacle transport container	A non-powered portable device designed for the transportation of clinical specimens contained within receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of designs whereby it may be thermally insulated and might include a non-powered cold pack(s). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10192253051216	GS1
Primary	50192253051214	GS1