BIOCOACH Blood Ketone Test Strips 50 Pack (Foil) S5640934

GUDID 00850017460089

50s

AMVENTUREX, INC.

Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent Ketone (acetoacetate) IVD, reagent

• Primary Device ID: 00850017460089
• NIH Device Record Key: 36032f9b-bc14-42f9-bedc-17482faae94e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOCOACH Blood Ketone Test Strips 50 Pack (Foil)
• Version Model Number: S5640934
• Catalog Number: S5640934
• 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	00850017460089 [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: 2023-06-08
• Device Publish Date: 2023-05-31

Devices Manufactured by AMVENTUREX, INC.

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• 00850017460065 - BIOCOACH Blood Glucose Test Strips 25s: 2022-01-05 25s
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