Intuitive Depth Exchange™ Catheter (IDE)

GUDID 00860581002677

Exchange Catheter with intuitive colored depth system, 70 CM, 15 Fr, not made with natural rubber latex, single use, sterile, fits 6.0 and larger ID tubes.

Through The Cords, LLC

Endotracheal tube guide, single-use

• Primary Device ID: 00860581002677
• NIH Device Record Key: acbf4154-789d-455f-9cee-1fd89f2ce20b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intuitive Depth Exchange™ Catheter (IDE)
• Version Model Number: 000294
• Company DUNS: 080585251
• Company Name: Through The Cords, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860581002660 [Primary]
GS1	00860581002677 [Package]; Contains: 00860581002660; Package: Box [10 Units]; In Commercial Distribution
GS1	00860581002684 [Package]; Package: Case [100 Units]; In Commercial Distribution

FDA Product Code

• BSR: Stylet, Tracheal Tube

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: 2022-12-15
• Device Publish Date: 2022-12-07

Devices Manufactured by Through The Cords, LLC

• 00850059297070 - Runnels Steerable Introducer™ #2.5 Oral/Nasal: 2024-10-31 Pre-lubricated articulating introducer with intuitive colored depth system, 67 CM, 12 Fr, latex free, single use, sterile, fits
• 00850059297018 - Runnels Steerable Introducer™ #5 Nasal: 2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 91.5 CM, 15 Fr, latex free, single use, sterile, fit
• 00850059297049 - Runnels Steerable Introducer™ #2 Oral/Nasal: 2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 62 CM, 12 Fr, latex free, single use, sterile, fits
• 00850059297100 - Runnels Steerable Introducer™ #3 Oral/Nasal: 2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 67 CM, 15 Fr, latex free, single use, sterile, fits
• 00850059297131 - Runnels Steerable Introducer™ DLT (35F/37F): 2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 86.5 CM, 12 Fr, latex free, single use, sterile, fit
• 00850059297162 - Runnels Steerable Introducer™ DLT (39F/41F): 2024-10-30 Pre-lubricated articulating introducer with intuitive colored depth system, 86.5 CM, 15 Fr, latex free, single use, sterile, fit
• 00850059297223 - Runnels Steerable Introducer™ #4 Oral: 2024-04-01 Pre-lubricated articulating introducer with intuitive colored depth system, 70 CM, 15 Fr, latex free, single use, sterile, fits
• 00850059297193 - Runnels Steerable Introducer™ #4 Nasal: 2024-02-05 Pre-lubricated articulating introducer with intuitive colored depth system, 77 CM, 15 Fr, latex free, single use, sterile, fits