BIOCOACH Glucose Control Solution L1/L2 S5800382

GUDID 00850017460058

Level 1 & 2

AMVENTUREX, INC.

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• Primary Device ID: 00850017460058
• NIH Device Record Key: 776adc13-de91-4c07-b893-a2859a20e534
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOCOACH Glucose Control Solution L1/L2
• Version Model Number: S5800382
• Catalog Number: S5800382
• Company DUNS: 117225590
• Company Name: AMVENTUREX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	00850017460058 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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

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• 00860060002327 - KETOCOACH 50 BLOOD KETONE TEST STRIPS: 2020-01-07