TriniLIZE™ Stabilyte tubes

Basic Information

• Brand Name: TriniLIZE™ Stabilyte tubes
• Primary DI: 15391521421286
• Version / Model: T6006
• Company Name: TCOAG IRELAND LIMITED
• Labeler DUNS: 985039126
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2019-07-19
• Public Version Status: Update
• Public Device Record Key: b493f84a-cbb1-46a0-9fbc-b9297e2b90c1
• Distribution End Date: 2019-04-01

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42585	Evacuated blood collection tube IVD, sodium citrate	A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the blood anticoagulant sodium citrate. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., for plasma coagulation studies, mononuclear cell preparation). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15391521421286	GS1
Unit of Use	05391521421289	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius