Complete one source kit AMS310

GUDID M896AMS3101

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: M896AMS3101
• NIH Device Record Key: 99fd58ab-f8cf-49e4-9ac1-4d036f17d077
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Complete one source kit
• Version Model Number: AMS310
• Catalog Number: AMS310
• 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	M896AMS3100 [Primary]
HIBCC	M896AMS3101 [Package]; Contains: M896AMS3100; 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: 2016-09-12

On-Brand Devices [Complete one source kit]

• M896TRU3100: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896AMS3120: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa
• M896AMS3101: Sterile Disposable Kit containing single-patient-use components necessary for each platelet sepa