Autologous Platelet Separator Disposables Kit MDK300

GUDID M896MDK3000

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: M896MDK3000
• NIH Device Record Key: 446b648e-4353-42ea-b3e5-c53d2462d448
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Autologous Platelet Separator Disposables Kit
• Version Model Number: MDK300
• Catalog Number: MDK300
• 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	M896MDK3000 [Primary]
HIBCC	M896MDK3001 [Package]; Package: Box [5 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: 2016-09-09

Devices Manufactured by ARTERIOCYTE MEDICAL SYSTEMS, INC.

• M896IFLXMAX020 - Magellan Influx: 2023-06-14 MAR0 Kit with 2.5cc Influx Max
• M896AMS500220500 - Precise: 2023-06-07 Precise Separation Canister, 60 mL
• M896AMS500220530 - Precise: 2023-06-07 Precise Separation Canister, 60mL
• M896AMS500220560 - Precise: 2023-06-07 Precise Separation Canister, 60 mL
• 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