co-innovation

Basic Information

• Brand Name: co-innovation
• Primary DI: 06970429843318
• Version / Model: FYL TEST
• Company Name: Co-Innovation Biotech Co., Ltd
• Labeler DUNS: 421302978
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-20
• Public Version: 1
• Public Version Date: 2024-08-28
• Public Version Status: New
• Public Device Record Key: d801af13-bb9c-438d-af40-2aca4d8cd103
• Distribution End Date: 2024-08-20

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55632	Fentanyl IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of fentanyl in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16970429843315	GS1		10	Not in Commercial Distribution	2024-08-20
Primary	06970429843318	GS1
Package	26970429843312	GS1		20	Not in Commercial Distribution	2024-08-20
Package	36970429843319	GS1		25	Not in Commercial Distribution	2024-08-20
Package	46970429843316	GS1		100	Not in Commercial Distribution	2024-08-20

Premarket Submissions

Submission Number	Supplement Number
K241100	000