Wondfo

Basic Information

• Brand Name: Wondfo
• Primary DI: 00816862024357
• Version / Model: WS-H5L20
• Company Name: WONDFO USA CO., LTD.
• Labeler DUNS: 849098897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2024-05-24
• Public Version: 1
• Public Version Date: 2024-06-03
• Public Version Status: New
• Public Device Record Key: 691a91d4-549b-45e3-8b1b-4a72d0d2656e

Device Description

5-Strip HCG Pregnancy Tests,20-Strip LH-Ovulation Test, and 25 Plastic Urine Cups

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
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	862.1155	2
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	862.1485	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60862	Natural conception assistance kit	A collection of devices intended to improve the likelihood of natural conception by monitoring ovulation and supplementing essential vitamins. The kit may contain in vitro diagnostic medical devices (IVDs) such as immunochromatographic tests for ovulation and pregnancy detection, a digital thermometer, vitamin supplements for the male and the female, and instructions for use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816862024354	GS1		120	In Commercial Distribution
Primary	00816862024357	GS1
Unit of Use	00816862024364	GS1

Customer Contacts

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

Storage Conditions

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