WELLlife™

Basic Information

• Brand Name: WELLlife™
• Primary DI: 00816862026030
• Version / Model: WFTY-POC1W-25BX
• Company Name: WONDFO USA CO., LTD.
• Labeler DUNS: 849098897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2024-12-24
• Public Version: 1
• Public Version Date: 2025-01-01
• Public Version Status: New
• Public Device Record Key: 74a9bde1-6c0f-420e-8592-bb2080e87b0c

Device Description

1-Panel Card; FTY Fentanyl 1 ng/ml POC CLIA Waived; 25 Tests/Kitbox

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: 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
64153	Fentanyl IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of fentanyl in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816862026037	GS1		45	In Commercial Distribution
Primary	00816862026030	GS1
Unit of Use	00816862026023	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K241741	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius