SAFElife™

GUDID 10816862024972

1-Cassette; FTY Fentanyl 1 ng/ml OTC; 10 Tests/Kitbox

WONDFO USA CO., LTD.

Fentanyl IVD, kit, rapid ICT, clinical

• Primary Device ID: 10816862024972
• NIH Device Record Key: e07db76d-a550-4780-8001-6d5e8deb8a09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAFElife™
• Version Model Number: WDFT-201-OTC1-10BX
• Company DUNS: 849098897
• Company Name: WONDFO USA CO., LTD.
• Device Count: 10
• 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	00816862024968 [Unit of Use]
GS1	00816862024975 [Primary]
GS1	10816862024972 [Package]; Contains: 00816862024975; Package: [72 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 [SAFElife™]

• 10816862026570: 10-Panel T-Cup Compact; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC with CR/pH/S.G.
• 10816862026556: 10-Panel T-Cup Compact; AMP,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,THC
• 10816862026532: 14-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC with CR/pH/S.G
• 10816862026518: 14-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
• 10816862026495: 12-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC with CR/pH/S.G.
• 10816862026471: 12-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC
• 10816862026419: 6-Panel T-Cup Compact; AMP,BZO,COC,mAMP,OPI,THC
• 10816862026396: 13-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC with CR/pH/S.G.
• 10816862026372: 13-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
• 10816862026358: 14-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,PPX,TCA,THC with CR/pH/S.G
• 10816862026136: SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 25 Test/Box
• 10816862026112: SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 10 Test/Box
• 10816862026099: SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel 1 ng/ml OTC; 5 Test/Box
• 10816862025955: 1-Panel Card; FTY Fentanyl 1 ng/ml OTC; 1 Test/Kitbox
• 10816862025917: 1-Panel Card; FTY Fentanyl 1 ng/ml OTC; 10 Tests/Kitbox
• 10816862025894: 1-Panel Card; FTY Fentanyl 1 ng/ml OTC; 25 Tests/Kitbox
• 10816862024972: 1-Cassette; FTY Fentanyl 1 ng/ml OTC; 10 Tests/Kitbox
• 10816862024958: 1-Cassette; FTY Fentanyl 1 ng/ml OTC; 25 Tests/Kitbox