Topcare

Basic Information

• Brand Name: Topcare
• Primary DI: 00036800163201
• Version / Model: One Step Ovulation Predictor
• Company Name: TOPCO ASSOCIATES, LLC
• Labeler DUNS: 072943876
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 7
• Record Status: Published
• Publish Date: 2019-02-06
• Public Version: 2
• Public Version Date: 2023-03-30
• Public Version Status: Update
• Public Device Record Key: b8679a81-e575-47c0-960c-485880fd310a
• Distribution End Date: 2023-03-29

Device Description

WWOT Topcare OVS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
CEP	Radioimmunoassay, Luteinizing Hormone	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
Primary	00036800163201	GS1
Unit of Use	00633472000140	GS1
Package	10036800163208	GS1	Shipping Case	6	Not in Commercial Distribution	2023-03-29

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius