Surgical Tools for Erythrocyte and Marrow Preparation Kit

GUDID M896MAR01O1051

Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: M896MAR01O1051
• NIH Device Record Key: 26ab1af3-d7dc-4853-bc93-3fc37402e346
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Tools for Erythrocyte and Marrow Preparation Kit
• Version Model Number: MAR01-O-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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M896MAR01O1050 [Primary]
HIBCC	M896MAR01O1051 [Package]; Contains: M896MAR01O1050; Package: Box [1 Units]; In Commercial Distribution

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: 2020-12-22
• Device Publish Date: 2020-12-14

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

• M896MAR01O250: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896MAR01O1051: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa