BIOCOACH Blood Glucose and Ketone Monitoring System S84102

GUDID 00850017460034

Complete Kit

AMVENTUREX, INC.

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• Primary Device ID: 00850017460034
• NIH Device Record Key: 4ee87e06-8a99-4b33-a931-c4ce5e401707
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOCOACH Blood Glucose and Ketone Monitoring System
• Version Model Number: S84102
• Catalog Number: S84102
• 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: true
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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	00850017460034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201880

FDA Product Code

• JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)

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: 2022-01-05
• Device Publish Date: 2021-12-28

Devices Manufactured by AMVENTUREX, INC.

• 00850017460089 - BIOCOACH Blood Ketone Test Strips 50 Pack (Foil): 2023-06-08 50s
• 00850017460287 - BIOCOACH Blood Glucose Test Strips 50 Pack (Foil): 2023-06-08 50s
• 00850017460027 - BIOCOACH Blood Glucose Test Strips 50s: 2022-01-05 50s
• 00850017460034 - BIOCOACH Blood Glucose and Ketone Monitoring System: 2022-01-05Complete Kit
• 00850017460034 - BIOCOACH Blood Glucose and Ketone Monitoring System: 2022-01-05 Complete Kit
• 00850017460058 - BIOCOACH Glucose Control Solution L1/L2: 2022-01-05 Level 1 & 2
• 00850017460065 - BIOCOACH Blood Glucose Test Strips 25s: 2022-01-05 25s
• 00860060002310 - KETOCOACH BLOOD KETONE METER: 2020-01-07
• 00860060002327 - KETOCOACH 50 BLOOD KETONE TEST STRIPS: 2020-01-07