POPS! one Blood Glucose Monitoring System

GUDID 04713106029788

POPS! DIABETES CARE, INC.

Glucose analyser IVD, home-use

• Primary Device ID: 04713106029788
• NIH Device Record Key: 996fb0c8-e957-4ee6-8dcd-62bfbbf27e30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POPS! one Blood Glucose Monitoring System
• Version Model Number: TD-4142
• Company DUNS: 053522562
• Company Name: POPS! DIABETES CARE, 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: false
• Serial Number: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04713106029788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181588

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2019-02-28
• Device Publish Date: 2019-01-28

On-Brand Devices [POPS! one Blood Glucose Monitoring System]

• 04713106029788: TD-4142
• 00860421000498: TD-4142