Reavillmed, LLC

GUDID 00863523000304

REAVILLMED, LLC

Invasive blood pressure monitoring tubing set

• Primary Device ID: 00863523000304
• NIH Device Record Key: 8d142a90-0156-44dc-8c67-2478c84117a2
• Commercial Distribution Discontinuation: 2019-10-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Reavillmed, LLC
• Version Model Number: 660925B
• Company DUNS: 806747155
• Company Name: REAVILLMED, LLC
• 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: 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	00863523000304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101189

FDA Product Code

• LJS: Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-11
• Device Publish Date: 2016-12-27