TempoSmart

GUDID B553TEMPOSMART110

TempoSmart™ 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. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.

WELLDOC, INC.

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• Primary Device ID: B553TEMPOSMART110
• NIH Device Record Key: 8d4fa4b7-eeb5-4458-b197-282269e5483e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TempoSmart
• Version Model Number: v1.1
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553TEMPOSMART110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190013

FDA Product Code

• LNX: Medical Computers And Software

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: 2023-08-15
• Device Publish Date: 2023-08-07

On-Brand Devices [TempoSmart]

• B553TEMPOSMART100: TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare provide
• B553TEMPOSMART110: TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare provide
• B553202174RX0: TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare provide
• B553202173OTC0: TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare provide
• B553202172RX0: TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare provide
• B553202171OTC0: TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare provide