DEVICE: OneTouch Reveal Plus (B553OTREVEALPLUS150)

Device Identifier (DI) Information

OneTouch Reveal Plus
v1.5
Not in Commercial Distribution

WELLDOC, INC.
B553OTREVEALPLUS150
HIBCC
March 31, 2023
1
021217115 *Terms of Use
OneTouch Reveal Plus is a private-labeled version of BlueStar. DIABETES SUPPORT, ANYTIME ANYWHERE™ BlueStar 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. BlueStar’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. BlueStar 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 BlueStar 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 BlueStar is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes. BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, and educational coaching messages to aid in diabetes self-management. BlueStar 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, 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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61215 Home pharmaceutical management support software
A software package intended to be used by patients at home, and healthcare professionals in a clinical setting, to facilitate therapeutic pharmaceutical management decisions (e.g., dosage) by providing suggested regimes for individual patients based on their physical and laboratory data. It is intended to be used on a non-medical computerized device (e.g., to be used on mobile devices at point-of-care); it is not intended to support anaesthesia administration.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MRZ Accessories, Pump, Infusion
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4575621f-2951-480a-be8d-8815ab9bcf23
November 03, 2023
5
August 12, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
1-888-611-4794
connect@welldoc.com
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