Magellan Influx

GUDID M896IFLXMAX020

MAR0 Kit with 2.5cc Influx Max

ARTERIOCYTE MEDICAL SYSTEMS, INC.

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• Primary Device ID: M896IFLXMAX020
• NIH Device Record Key: 5daaa5a3-543b-49d8-a7e3-c274e862e1ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magellan Influx
• Version Model Number: IFLX-MAX-02
• Company DUNS: 809012870
• Company Name: ARTERIOCYTE MEDICAL SYSTEMS, 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: true
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• 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	M896IFLXMAX020 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-14
• Device Publish Date: 2023-06-06

Devices Manufactured by ARTERIOCYTE MEDICAL SYSTEMS, INC.

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• M896IFLXMAX020 - Magellan Influx: 2023-06-14 MAR0 Kit with 2.5cc Influx Max
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• M896AMS500350500 - Precise: 2023-06-07 Precise Separation Canister, 120 mL
• M896AMS500350530 - Precise: 2023-06-07 Precise Separation Canister, 120 mL
• M896AMS500350560 - Precise: 2023-06-07 Precise Separation Canister, 120 mL
• M896PRCDIA0600 - Precise Diamond: 2023-06-07 Precise Diamond - 60 mL LP Kit