ClearCell® FX1 Unit

GUDID 08885016030003

BIOLIDICS LIMITED

Blood cell diluter Blood cell diluter Blood cell diluter Blood cell diluter Blood cell diluter Blood cell diluter Blood cell diluter Blood cell diluter Blood cell diluter Blood cell diluter Blood cell diluter Blood cell diluter Blood cell diluter Blood cell diluter

• Primary Device ID: 08885016030003
• NIH Device Record Key: 2363c541-c1b4-4e4e-8aca-54a8741ae73c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearCell® FX1 Unit
• Version Model Number: CBB-F011001-C
• Company DUNS: 595253935
• Company Name: BIOLIDICS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08885016030003 [Primary]

FDA Product Code

• GKH: Apparatus, Automated Blood Cell Diluting

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-03
• Device Publish Date: 2022-09-24