Truer Bougie

GUDID 00859290006236

Truer Medical’s new Bougie is a latex free, calibrated introducer designed to ensure accurate distance insertion. Truer Medical’s Bougie is the most adaptable, cost effective bougie available in the market. Low density polyethylene frosted finish sheath reduces friction and provides proper stiffness for ease of insertion. Multiple depth marks and malleable for straight or coudé tip.

TRUER MEDICAL, INC.

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• Primary Device ID: 00859290006236
• NIH Device Record Key: 5811532c-f88d-4f43-8210-5a2b1e4fd657
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Truer Bougie
• Version Model Number: 90552
• 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	00859290006236 [Primary]
GS1	10859290006233 [Package]; Package: carton [10 Units]; In Commercial Distribution
GS1	30859290006237 [Package]; Contains: 10859290006233; Package: carton [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: 2022-09-06
• Device Publish Date: 2022-08-29

Devices Manufactured by TRUER MEDICAL, INC.

• 00859290006472 - HP to 3.5mm Phonojack Cable with Shrinkwrap: 2024-01-24 HP to 3.5mm Phonojack Cable with Shrinkwrap
• 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: 2022-09-06Truer Medical’s new Bougie is a latex free, calibrated introducer designed to ensure accurate distance insertion. Truer Medical’s Bougie is the most adaptable, cost effective bougie available in the market. Low density polyethylene frosted finish sheath reduces friction and provides proper stiffness for ease of insertion. Multiple depth marks and malleable for straight or coudé tip.
• 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