Magellan Complete One Source Kit

GUDID M896AMS3160

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: M896AMS3160
• NIH Device Record Key: 71871350-825d-4114-9497-2b20dbe2ae96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magellan Complete One Source Kit
• Version Model Number: AMS316
• 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	M896AMS3160 [Primary]
HIBCC	M896AMS3161 [Package]; Package: [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: 2020-04-20
• Device Publish Date: 2020-03-04

On-Brand Devices [Magellan Complete One Source Kit]

• M896AMS3140: Sterile Disposable Kit Containing single patient-use components necessary for each platelet sepa
• M896AMS3160: AMS316