ASTUTE140 Electronic Quality Control (EQC) Device 400016

GUDID B0744000160

ASTUTE MEDICAL, INC.

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• Primary Device ID: B0744000160
• NIH Device Record Key: 81f2d37d-0568-45bd-806e-9c234d3c74b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASTUTE140 Electronic Quality Control (EQC) Device
• Version Model Number: 400016
• Catalog Number: 400016
• Company DUNS: 942854212
• Company Name: ASTUTE MEDICAL, 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0744000160 [Primary]

FDA Product Code

• PIG: Acute Kidney Injury Test System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-12

Devices Manufactured by ASTUTE MEDICAL, INC.

• B0744000160 - ASTUTE140 Electronic Quality Control (EQC) Device: 2018-03-29
• B0744000160 - ASTUTE140 Electronic Quality Control (EQC) Device: 2018-03-29
• B0745000090 - NEPHROCHECK Calibration Verification (Cal Vers) Ki: 2018-03-29 The NEPHROCHECK Calibration Verification (Cal Vers) Materials are to verify calibration of the NEPHROCHECK Test System.
• B0745000110 - NEPHROCHECK Test Kit: 2018-03-29 The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who curren
• B0745000130 - NEPHROCHECK Liquid Control Kit: 2018-03-29 The NEPHROCHECK Liquid Controls are used for the quality control monitoring of the NEPHROCHECK Test System.
• B0745000170 - ASTUTE140 Meter Kit: 2018-03-29