Pulse by EHE Health

GUDID B553PULSE100

Pulse by EHE Health (“Pulse”) 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. Pulse is intended to assist patients in managing their diabetes with guidance from their providers.

WELLDOC, INC.

Pharmaceutical management support software, patient-/professional-use

• Primary Device ID: B553PULSE100
• NIH Device Record Key: 75e75793-fae0-4214-ba9c-4abf1ec8f78a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse by EHE Health
• 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: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com
• Phone: 18886114794
• Email: connect@welldoc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553PULSE100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190013

FDA Product Code

• MRZ: Accessories, Pump, Infusion

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: 2022-05-10
• Device Publish Date: 2022-05-02

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• B553202058OTC0 - Welldoc App for Diabetes in Pregnancy and Insulin Pump Users: 2025-01-06 The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intende
• B553202141OTC0 - LivingConnected Diabetes Rx: 2024-12-12 LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabetes and LivingConnected Diabetes R
• B553202142RX0 - LivingConnected Diabetes: 2024-12-12 LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabetes and LivingConnected Diabetes R
• B553202143OTC0 - LivingConnected Diabetes: 2024-12-12 LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabetes and LivingConnected Diabetes R
• B553202144RX0 - LivingConnected Diabetes Rx: 2024-12-12 LivingConnected® powered by CCS Health (“LivingConnected”) includes LivingConnected Diabetes and LivingConnected Diabetes R
• B553202001OTC0 - Bluestar: 2024-10-02 BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged
• B553202002RX0 - Bluestar Rx: 2024-10-02 BlueStar® Rx is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients –