Truer Bougie Coiled

GUDID 10859290006462

Truer Medical’s new Bougie is a latex-free, calibrated introducer designed to ensure accurate distance insertion.

TRUER MEDICAL, INC.

Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use Endotracheal tube introducer, single-use

• Primary Device ID: 10859290006462
• NIH Device Record Key: 514078d3-982e-45eb-af5f-62b1a8bd3539
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Truer Bougie Coiled
• Version Model Number: 90553
• Company DUNS: 003530786
• Company Name: TRUER MEDICAL, INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859290006465 [Primary]
GS1	10859290006462 [Package]; Contains: 00859290006465; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• KCD: Bougie, Esophageal, Ent

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-02
• Device Publish Date: 2023-09-22

Devices Manufactured by TRUER MEDICAL, INC.

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• 10859290006462 - Truer Bougie Coiled: 2023-10-02Truer Medical’s new Bougie is a latex-free, calibrated introducer designed to ensure accurate distance insertion.
• 10859290006462 - Truer Bougie Coiled: 2023-10-02 Truer Medical’s new Bougie is a latex-free, calibrated introducer designed to ensure accurate distance insertion.
• 00859290006441 - 400 Series Right Angle Cable (80 cm): 2023-07-27 Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing tempera
• 00859290006458 - 400 Series Right Angle Cable (160 cm): 2023-07-27 Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing tempera
• 10859290006417 - Nasal Cannula: 2022-09-16 Adult Nasal Cannula w/7' safety channel tubing
• 00859290006236 - Truer Bougie: 2022-09-06 Truer Medical’s new Bougie is a latex free, calibrated introducer designed to ensure accurate distance insertion. Truer Medica
• 00859290006366 - HP 400 series type monitor cable: 2022-07-14 Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing tempera
• 00859290006373 - 400 Series Type Monitor Cable, Right Angle: 2022-07-14 Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing tempera