BioSentry® H787768022019S1

GUDID 00884450808122

Merit Medical Systems, Inc.

Lung biopsy procedure kit

• Primary Device ID: 00884450808122
• NIH Device Record Key: 710e6932-423e-4d27-b384-7791d9b7930c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioSentry®
• Version Model Number: A
• Catalog Number: H787768022019S1
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450808122 [Primary]

FDA Product Code

• OMT: Absorbable lung biopsy plug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-22
• Device Publish Date: 2024-03-14

Devices Manufactured by Merit Medical Systems, Inc.

• 10884450834111 - PAL™: 2024-11-05
• 20884450831513 - Tru-Cut®: 2024-11-05
• 10884450845308 - KyphoFlex™: 2024-11-04
• 10884450845315 - KyphoFlex™: 2024-11-04
• 10884450845322 - KyphoFlex™: 2024-11-04
• 20884450851269 - Merit Medical®: 2024-11-04
• 20884450834408 - Prelude EASE™: 2024-11-01
• 10884450730802 - Impress®: 2024-10-30