OneTouch Reveal Plus Rx

FDA UDI

Class II (US FDA UDI)

by Welldoc

Identity

Trade Name: OneTouch Reveal Plus Rx FDA UDI
Generic Name: Home pharmaceutical management support software FDA UDI
Device Name: OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2 diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for a healthier, happier you. BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while providing you with diabetes education and motivational support. COORDINATE YOUR CARE WITH YOUR DOCTOR Before your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcare provider understand the challenges that you face between appointments so that during your office visit you can discuss a treatment plan that is just right for you. INDICATION FOR USE BlueStarRx is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes. BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and educational coaching messages to aid in diabetes self-management. BlueStarRx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. BlueStarRx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who are pregnant. IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an emergency, plea FDA UDI
Model / Reference: v1.4 FDA UDI
Description: OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2 diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works with you, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes for a healthier, happier you. BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions while providing you with diabetes education and motivational support. COORDINATE YOUR CARE WITH YOUR DOCTOR Before your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcare provider understand the challenges that you face between appointments so that during your office visit you can discuss a treatment plan that is just right for you. INDICATION FOR USE BlueStarRx is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes. BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and educational coaching messages to aid in diabetes self-management. BlueStarRx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. BlueStarRx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who are pregnant. IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing an emergency, plea FDA UDI

Identifiers

Primary DI / UDI-DI: B553OTREVEALPLUSRX140 FDA UDI
510(k) Number: K162532 FDA UDI
FDA Product Code: MRZ FDA UDI
GMDN Term: Home pharmaceutical management support software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

OneTouch Reveal Plus Rx by Welldoc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K162532 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Welldoc

Sources (1)

FDA UDI 891e1f2a-fcf6-4dd9-90c0-5932b3e52063 36 fields · synced Jun 1, 2026