| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 07350014630285 | 0001 | PYT,NGE | Device, Fertility Diagnostic, Contraceptive, Software Application,Test, Luteiniz Device, Fertility Diagnostic, Contraceptive, Software Application,Test, Luteinizing Hormone (Lh), Over The Counter | 1 | Clearblue by NC | ||
| 2 | 07350014630209 | 20 | Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermomet Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermometer, 10 ovulation strip tests and 5 pregnancy strip tests. | LCX,PYT,NGE | Kit, Test, Pregnancy, Hcg, Over The Counter,Device, Fertility Diagnostic, Contra Kit, Test, Pregnancy, Hcg, Over The Counter,Device, Fertility Diagnostic, Contraceptive, Software Application,Test, Luteinizing Hormone (Lh), Over The Counter | 1 | Natural Cycles | |
| 3 | 07350014630155 | 15 | Test, Pregnancy, Hcg, Over The Counter | LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | Natural Cycles | |
| 4 | 07350014630148 | 14 | Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Test, Luteinizing Hormone (Lh), Over The Counter | 1 | Natural Cycles | |
| 5 | 07350014630131 | 13 | Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermo Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app. | PYT | Device, Fertility Diagnostic, Contraceptive, Software Application | 2 | Natural Cycles |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B441SMWINCLIENTAPP0 | 3.0.6.1 | SMWINCLIENTAPP | Spaulding Client Application is a web based application for trained users of the Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing a Windows platform. | Spaulding Client App | SPAULDING MEDICAL |
| 2 | B441SMIOSCLIENTAPP0 | 1.3.6.1 | SMIOSCLIENTAPP | Spaulding Client Application is a web based application for trained users of the Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform. | Spaulding Client App | SPAULDING MEDICAL |
| 3 | B441SMANDCLIENTAPP0 | 1.2.6.1 | SMANDCLIENTAPP | Spaulding Client Application is a web based application for trained users of the Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an Android platform. | Spaulding Client App | SPAULDING MEDICAL |
| 4 | 07350014630285 | 0001 | Clearblue by NC | NATURALCYCLES NORDIC AB | ||
| 5 | 07350014630209 | 20 | Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermomet Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermometer, 10 ovulation strip tests and 5 pregnancy strip tests. | Natural Cycles | NATURALCYCLES NORDIC AB | |
| 6 | 07350014630131 | 13 | Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermo Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app. | Natural Cycles | NATURALCYCLES NORDIC AB | |
| 7 | 07350014630124 | B | Natural Cycles | NATURALCYCLES NORDIC AB | ||
| 8 | 04260749840008 | 1 | Clue Birth Control is a feature of the Clue period tracker mobile application. C Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control’s proprietary algorithm uses period start date information entered by the user to provide predictions of “high risk days” and “low risk days” for becoming pregnant based on a Fertility Awareness Based Method (FABM) of contraception. Identification of high risk days allows the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy. To use Clue Birth Control, users go through an onboarding process from within the Clue app, during which they are asked to provide information that will determine whether they meet the Clue Birth Control use criteria. Clue Birth Control can only be used by women who are between 18 and 45 years old and their last 12 cycles were between 20 and 40 days and the difference between the lengths of the shortest and longest cycles is less than or equal to 9 days. In addition, users must have had at least three cycles (four periods) after stopping hormonal birth control (HBC) or since the end of a pregnancy. | Clue | BIOWINK GMBH |