CP Disposable Kit

GUDID M896CLPTPK1011

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: M896CLPTPK1011
• NIH Device Record Key: 8cb77209-fb95-4418-ad4a-4ce241171f7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CP Disposable Kit
• Version Model Number: CLPT-PK-101
• Company DUNS: 809012870
• Company Name: ARTERIOCYTE MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M896CLPTPK1010 [Primary]
HIBCC	M896CLPTPK1011 [Package]; Contains: M896CLPTPK1010; Package: [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: 2
• Public Version Date: 2019-04-09
• Device Publish Date: 2018-12-12

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