Cologuard Stool Buffer

GUDID 00858637005185

EXACT SCIENCES CORPORATION

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 00858637005185
• NIH Device Record Key: f497c024-9369-4ece-b0b8-abdebf7a9d79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cologuard Stool Buffer
• Version Model Number: 200204
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00858637005185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130017

FDA Product Code

• PHP: System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-11-17

On-Brand Devices [Cologuard Stool Buffer]

• 00858637005185: 200204
• 00858637005178: 200204