ClearCell® FX1 Unit

GUDID 08885016030003

BIOLIDICS LIMITED

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