Surgical tools for erythrocyte & marrow preparation kit 40-K10-0001

GUDID M89640K1000010

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.

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• Primary Device ID: M89640K1000010
• NIH Device Record Key: 9924d233-ba76-4afb-b356-1068f2d0cc72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical tools for erythrocyte & marrow preparation kit
• Version Model Number: 40-K10-0001
• Catalog Number: 40-K10-0001
• Company DUNS: 809012870
• Company Name: ARTERIOCYTE MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 866-660-2674
• Email: customerservice@arteriocyte.co
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com
• Phone: 866-660-2674
• Email: customerservice@arteriocyte.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M89640K1000010 [Primary]
HIBCC	M89640K1000011 [Package]; Package: Box [1 Units]; In Commercial Distribution

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-09-12

On-Brand Devices [Surgical tools for erythrocyte & marrow preparation kit]

• M896TRUMAR0O800: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896TRUMAR0O450: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896MAR02O800: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896MAR02O450: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896MAR02O0: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896MAR01OFC0: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896MAR01O800: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896MAR01O450: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896MAR01O0: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896MAR01600: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896MAR010: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896AMSSV0: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M89640K1000010: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa