EsoCheck CCD Cell Collection Device

GUDID 00860002356013

The Lucid Diagnostics EsoCheck CCD Cell Collection Device is a sterile single-use disposable non-endoscopic balloon capsule catheter designed to collect and retrieve surface cells of the esophagus. The balloon capsule is attached to a catheter and swallowed with the balloon deflated and inverted. Once positioned, the balloon is inflated and withdrawn allowing its textured surface to swab the surface of the targeted segment of the esophagus, retrieving cells in the process. The balloon is then deflated, retracting it along with the retrieved cells on its surface into the capsule, where they are protected from dilution or contamination as the capsule is fully withdrawn from the patient. The balloon is cut from the capsule and placed in the desired specimen container. The specimen is then sent for diagnostic processing and analysis.

Lucid Diagnostics Inc

Cytology scraper, single-use

• Primary Device ID: 00860002356013
• NIH Device Record Key: 33de7d71-314b-4db0-8ade-8945856b20f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EsoCheck CCD Cell Collection Device
• Version Model Number: 260-03614
• Company DUNS: 117328426
• Company Name: Lucid Diagnostics 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

Customer Support Contacts

• Phone: 212-949-4319
• Email: info@LucidDX.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002356006 [Primary]
GS1	00860002356013 [Package]; Contains: 00860002356006; Package: Shelf Box [25 Units]; In Commercial Distribution
GS1	00860002356020 [Package]; Contains: 00860002356006; Package: Shelf Box [5 Units]; In Commercial Distribution

FDA Product Code

• EOX: Esophagoscope (Flexible Or Rigid)

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: 2020-04-27
• Device Publish Date: 2019-12-17