Cologuard Capture Aspirator

GUDID 00858637005895

EXACT SCIENCES CORPORATION

Pipetting system IVD

• Primary Device ID: 00858637005895
• NIH Device Record Key: eabcef8e-e4ad-4ced-a47d-6affacd42198
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cologuard Capture Aspirator
• Version Model Number: 300490
• Company DUNS: 150908853
• Company Name: EXACT SCIENCES CORPORATION
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858637005895 [Primary]

FDA Product Code

• JQW: Station, Pipetting And Diluting, For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-17
• Device Publish Date: 2022-12-08

Devices Manufactured by EXACT SCIENCES CORPORATION

• 00858637005895 - Cologuard Capture Aspirator: 2026-02-17
• 00858637005895 - Cologuard Capture Aspirator: 2026-02-17
• 00858637005840 - Analysis Server v2.2: 2025-03-27 Exact Sciences Software System 2.2
• 00858637005857 - Analysis Client v2.2: 2025-03-27 Exact Sciences Software System 2.2
• 00858637005864 - STARlet Interface v2.2: 2025-03-27 Exact Sciences Software System 2.2
• 00858637005871 - Cycler Control v2.2: 2025-03-27 Exact Sciences Software System 2.2
• 00858637005888 - Cologuard Test Definition v1.7: 2025-03-27
• 00858637005901 - Cologuard 2 Test Definition: 2025-03-27
• 00858637005949 - The Cologuard Plus Collection Kit: 2025-03-27