MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit

GUDID M896MAR01JPN1050

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: M896MAR01JPN1050
• NIH Device Record Key: edd54316-11fa-46d0-a9b6-78b1087a0807
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit
• Version Model Number: MAR01-JPN-105
• Company DUNS: 809012870
• Company Name: ARTERIOCYTE MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com
• Phone: 508-435-7412
• Email: customerservice@arteriocyte.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M896MAR01JPN1050 [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: 2019-12-17
• Device Publish Date: 2019-12-09

On-Brand Devices [MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit]

• M896MAR01ATS0: Sterile Disposable Kit Containing single patient-use components necessary for each platelet sepa
• M896MAR01JPN450: MAR01-JPN-45
• M896MAR01JPN250: MAR01-JPN-25
• M896MAR01JPN1050: MAR01-JPN-105
• M896MAR01JPN800: MAR01-JPN-80