POPS! one Blood Glucose Monitoring System

GUDID 00860421000498

POPS! DIABETES CARE, INC.

Glucose analyser IVD, home-use

• Primary Device ID: 00860421000498
• NIH Device Record Key: ba05d6de-cbac-4be5-be7a-4dc1f7f88a25
• 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: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	00860421000498 [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: 2020-01-31
• Device Publish Date: 2020-01-23

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

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