Conception Kit

Basic Information

• Brand Name: Conception Kit
• Primary DI: 00895863001000
• Version / Model: CX-0002-ML EN/ES
• Catalog Number: CX-0002-ML EN/ES
• Company Name: CONCEIVEX INC.
• Labeler DUNS: 610032034
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-01
• Public Version: 2
• Public Version Date: 2019-02-21
• Public Version Status: Update
• Public Device Record Key: f4f509b2-c2d8-4952-80c6-fc6b66397f49

Device Description

Lot number, Expiration Date, Individual Kit Number, Temperature Range and the statement: The Conception Kit should be kept away from direct sunlight, moisture and heat.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
OBB	Kit, Conception-Assist, Home Use	Obstetrics/Gynecology	884.5250	2

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	00895863001000	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Wide 9 inches
Device Size Text, specify			lenght 10 inches
Device Size Text, specify			Height: 6 .5 inches

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 35 – 86 Degrees Fahrenheit