ILLUMISITE

GUDID 20884521842424

Patient Sensor Patches

Covidien LP

Multi-purpose surgical skin adhesive tape

• Primary Device ID: 20884521842424
• NIH Device Record Key: 1cc05510-812a-43b4-9bce-671785c98474
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ILLUMISITE
• Version Model Number: ILS-1000-SP
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 60
• 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: true
• Expiration Date: false
• 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: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521807983 [Primary]
GS1	20884521842424 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191394

FDA Product Code

• JAK: System, x-ray, tomography, computed

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-01-12
• Device Publish Date: 2020-11-04

On-Brand Devices [ILLUMISITE]

• 10884521779990: Planning Software V1.0
• 10884521779983: Procedure Software V1.0
• 10884521723993: Bronchoscope Adapter for se with Fujinon bronchoscopes
• 10884521723986: Bronchoscope Adapter for use with Pentax bronchoscopes
• 10884521723979: Bronchocope Adapter for use with Olyumpus 190 bronchoscope
• 10884521723962: Bronchoscope Adapter for use with Olympus bronchoscopes
• 10884521723955: Patient Sensor Patch
• 10884521723801: Bronchoscope Adapter for use with Fujinon bronchoscopes
• 10884521723795: Bronchoscope Adapter for use with Pentax bronchoscopes
• 10884521723788: Bronchoscope Adapter for use with Olympus 190 bronchoscopes
• 10884521723771: Bronchoscope Adapter for use with Olympus bronchoscopes
• 10884521723634: Console
• 10884521723832: Endobronchial Procedure Kit 45 Catheter
• 10884521723825: Endobronchial Procedure Kit 90 Catheter
• 10884521723818: Endobronchial Procedure Kit 180 Catheter
• 10884521812383: ILS-1000-CS ILLUMISITE CONSOLE EU
• 20884521807980: Patient Sensor Patches
• 10884521812413: Endobronchial Procedure Kit 45 Catheter
• 20884521842424: Patient Sensor Patches
• 10884521837096: Console
• 10884521842915: Console
• 10884521837157: Console
• 10884521837140: Console
• 10884521837133: Console
• 10884521837126: Console
• 10884521837102: Console