Resp-O2 Endotracheal Tube Introducer (Bougie), Adult, 15 FR

GUDID 00840117313361

DYNAREX CORPORATION

Endotracheal tube introducer, single-use

• Primary Device ID: 00840117313361
• NIH Device Record Key: b1db6776-4e3b-466c-bb1b-a9643555d5c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Endotracheal Tube Introducer (Bougie), Adult, 15 FR
• Version Model Number: 36261
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 10
• 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: false
• 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	00840117313361 [Primary]
GS1	00840117313378 [Package]; Package: Master Shipper [20 Units]; In Commercial Distribution
GS1	00840117322981 [Unit of Use]

FDA Product Code

• KBI: Bougie, Eustachian

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: 2022-05-24
• Device Publish Date: 2022-05-16

Devices Manufactured by DYNAREX CORPORATION

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• 00840117329768 - LabChoice Twelve Channel Pipette, Adjustable Volume 50-300 uL: 2025-06-09
• 00840117329782 - LabChoice Electronic Pipette, Single Channel, Adjustable Volume 30-300uL: 2025-06-09
• 00840117329799 - LabChoice Electronic Pipette, Eight Channel, Adjustable Volume, 0.5-10uL: 2025-06-09
• 00840117329805 - LabChoice Electronic Pipette, Eight Channel, Adjustable Volume 10-100 uL: 2025-06-09
• 00840117329812 - LabChoice Electronic Pipette, Eight Channel, Adjustable Volume, 30-300 uL: 2025-06-09