BABYLife

GUDID 10816862024415

25 Semi-Quantitative FSH Strips; Follicle Stimulating Hormone (FSH) 5/10/25/50 mIU/mL

WONDFO USA CO., LTD.

Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

• Primary Device ID: 10816862024415
• NIH Device Record Key: 6c9ae674-475f-4dca-8ea5-01f04ec788a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BABYLife
• Version Model Number: W52-S-SQ-25BX
• Company DUNS: 849098897
• Company Name: WONDFO USA CO., LTD.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816862024418 [Primary]
GS1	00816862024425 [Unit of Use]
GS1	10816862024415 [Package]; Contains: 00816862024418; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• NGA: Test, Follicle Stimulating Hormone (Fsh), 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: 2024-05-30
• Device Publish Date: 2024-05-22

Devices Manufactured by WONDFO USA CO., LTD.

• 10816862024354 - Wondfo: 2024-06-03 5-Strip HCG Pregnancy Tests,20-Strip LH-Ovulation Test, and 25 Plastic Urine Cups
• 10816862024378 - Wondfo: 2024-06-03 10-Strip HCG Pregnancy Tests,40-Strip LH-Ovulation Test, and 50 Plastic Urine Cups
• 00816862024470 - Wondfo: 2024-06-03 Prime Screen® Multi-Drug Urine Test Cup(12-Panel C-Cup: BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC), 1Test/ Box
• 10816862024262 - T-Cup: 2024-05-31 T-Cup with Vaccu Lid,3 SVT strips (CR/pH/S.G.) and Temp Strip
• 10816862024347 - Wondfo: 2024-05-31 1-Panel Cassette; LH Ovulation Test SCI
• 10816862024538 - Wondfo: 2024-05-31 10-Strips; Alcohol Saliva Test Box 10 Pcs
• 10816862024415 - BABYLife: 2024-05-3025 Semi-Quantitative FSH Strips; Follicle Stimulating Hormone (FSH) 5/10/25/50 mIU/mL
• 10816862024415 - BABYLife: 2024-05-30 25 Semi-Quantitative FSH Strips; Follicle Stimulating Hormone (FSH) 5/10/25/50 mIU/mL
• 10816862024439 - Prime Screen: 2024-05-30 12-Panel Card: AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC,5 per box