KETOCOACH METER ONLY

GUDID 00860060002341

AMVENTUREX, INC.

Ketone (acetoacetate) IVD, kit, spectrophotometry

• Primary Device ID: 00860060002341
• NIH Device Record Key: 86c0075a-0106-4015-a774-0258450946ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KETOCOACH METER ONLY
• Version Model Number: S11007
• Company DUNS: 117225590
• Company Name: AMVENTUREX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00860060002341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182593

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: 2020-01-07
• Device Publish Date: 2019-12-30

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: 2022-01-05 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