LivingConnected Diabetes Rx

GUDID B553LCDIABETESRX100

LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabetes and LivingConnected Diabetes Rx, which is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. LivingConnected Diabetes and LivingConnected Diabetes Rx are intended to assist patients in managing their diabetes with guidance from their providers. LivingConnected Diabetes Rx requires a prescription.

WELLDOC, INC.

Home pharmaceutical management support software

• Primary Device ID: B553LCDIABETESRX100
• NIH Device Record Key: a84b2183-4ba9-4c8e-9e26-6e3aa817c748
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LivingConnected Diabetes Rx
• Version Model Number: v1.0
• Company DUNS: 021217115
• Company Name: WELLDOC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553LCDIABETESRX100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203434

FDA Product Code

• NDC: Calculator, Drug Dose

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-03
• Device Publish Date: 2023-04-25

On-Brand Devices [LivingConnected Diabetes Rx]

• B553LCDIABETESRX100: LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabete
• B553LCDIABETESRX110: LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabete
• B553202144RX0: LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabete
• B553202141OTC0: LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabete