Cycle Tracking 3.0

Basic Information

• Brand Name: Cycle Tracking 3.0
• Primary DI: 00194252845974
• Version / Model: Feature Version 3.x
• Company Name: APPLE INC.
• Labeler DUNS: 060704780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-27
• Public Version: 2
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 25eb8c6f-dfc8-44a6-a39c-fa8c8ecafad0

Device Description

Cycle Tracking iPhone App (Version 3.0)

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHD	Device, Fertility Diagnostic, Proceptive	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
64008	Menstrual cycle self-monitoring software	An interpretive software application intended to be used on a non-medical computerized device to allow a healthy woman to monitor the fertile and infertile phases of her menstrual cycle in the home, to assist her in achieving natural conception or prevent undesired pregnancy. It uses the symptothermal method which is based on data from self-observed signs such as waking temperature, the nature of cervical secretions, and cervix position/hardness.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00194252845974	GS1