Magellan Complete Disposable Kit

GUDID M896MDK300JPN0

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: M896MDK300JPN0
• NIH Device Record Key: 744496d8-00e0-4c19-a8b1-eb867fc01862
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magellan Complete Disposable Kit
• Version Model Number: MDK300-JPN
• Company DUNS: 809012870
• Company Name: ARTERIOCYTE MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	M896MDK300JPN0 [Primary]
HIBCC	M896MDK300JPN1 [Package]; Package: Box [5 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: 2019-06-21
• Device Publish Date: 2019-06-13

On-Brand Devices [Magellan Complete Disposable Kit]

• M896MDK300JPN0: MDK300-JPN
• M896TRU300JPN1: TRU300-JPN