WELLlife™

GUDID 10816862026037

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

WONDFO USA CO., LTD.

Fentanyl IVD, kit, rapid ICT, clinical

• Primary Device ID: 10816862026037
• NIH Device Record Key: 74a9bde1-6c0f-420e-8592-bb2080e87b0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WELLlife™
• Version Model Number: WFTY-POC1W-25BX
• Company DUNS: 849098897
• Company Name: WONDFO USA CO., LTD.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816862026023 [Unit of Use]
GS1	00816862026030 [Primary]
GS1	10816862026037 [Package]; Contains: 00816862026030; Package: [45 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241741

FDA Product Code

• NGL: Test, Opiates, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-01
• Device Publish Date: 2024-12-24

On-Brand Devices [WELLlife™]

• 10816862024507: WELLlife™ COVID-19/Influenza A&B Home Test Cassette,2 Tests per Kitbox
• 10816862026235: WELLlife™ COVID-19 Antigen Home Test Cassette,2 Tests per Kitbox with Holder
• 00816862026177: WELLlife™ COVID-19 Antigen Home Test Cassette, 1 Test per Kitbox with Holder
• 10816862026297: WELLlife™ COVID-19 Antigen Home Test Cassette, 25 Tests per Kitbox
• 10816862026273: WELLlife™ COVID-19 Antigen Home Test Cassette, 10 Tests per Kitbox
• 10816862026259: WELLlife™ COVID-19 Antigen Home Test Cassette, 5 Tests per Kitbox
• 10816862024729: WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 25 Tests per Kitbox
• 10816862024705: WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 10 Tests per Kitbox
• 10816862024682: WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 5 Tests per Kitbox
• 10816862024668: WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 2 Tests per Kitbox
• 10816862024637: WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 1 Test per Kitbox
• 10816862024606: WELLlife™ COVID-19/Influenza A&B Test Control Kit, 5 Positive Control Swabs and 5 Negative Con
• 10816862024583: WELLlife™ COVID-19/Influenza A&B Test Cassette, 25 Tests per Kitbox
• 10816862026150: WELLlife™ COVID-19/Influenza A&B Home Test Cassette, 2 Tests per Kitbox with Holder; SD
• 10816862026037: 1-Panel Card; FTY Fentanyl 1 ng/ml POC CLIA Waived; 25 Tests/Kitbox
• 10816862026013: 1-Panel Cassette; FTY Fentanyl 1 ng/ml POC CLIA Waived; 25 Tests/Kitbox
• 10816862025979: 1 iFOB Fecal Occult Blood Test OTC; 1 Cassettes + 1 Collection Tube + 1 Collection Paper
• 10816862025870: 1-Cassette; FTY Fentanyl 1 ng/ml OTC; 1 Test/Kitbox
• 10816862024996: 1-Cassette; FTY Fentanyl 1 ng/ml OTC; 5 Tests/Kitbox