Identity
- Trade Name
- BlueStarRx FDA UDI
- Generic Name
- Home pharmaceutical management support software FDA UDI
- Device Name
- 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 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 21 years and older, who have 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 is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. CONTRAINDICATIONS: Type 1 diabetes, patients on insulin pumps, patients less than 21 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, please dial 911. Caution: Federal law restricts this device to sale by or on the order of a physician. For more information visit www.bluestardiabetes.com FDA UDI
- Model / Reference
- v5.1 FDA UDI
- Description
- 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 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 21 years and older, who have 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 is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. CONTRAINDICATIONS: Type 1 diabetes, patients on insulin pumps, patients less than 21 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, please dial 911. Caution: Federal law restricts this device to sale by or on the order of a physician. For more information visit www.bluestardiabetes.com FDA UDI
Identifiers
- Primary DI / UDI-DI
- B553BLUESTARRX510 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Home pharmaceutical management support software
BlueStarRx by Welldoc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Welldoc
Sources (1)
- FDA UDI f9d56431-f0a2-4a8b-8cd5-dd4ab257cebf 35 fields · synced May 31, 2026