BIOCOACH Blood Glucose Test Strips 50 Pack (Foil) S5640936

GUDID 00850017460287

50s

AMVENTUREX, INC.

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• Primary Device ID: 00850017460287
• NIH Device Record Key: b623091f-8d79-465e-b736-96132e04f67d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOCOACH Blood Glucose Test Strips 50 Pack (Foil)
• Version Model Number: S5640936
• Catalog Number: S5640936
• Company DUNS: 117225590
• Company Name: AMVENTUREX, 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: 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	00850017460287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201880

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: 2023-06-08
• Device Publish Date: 2023-05-31

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