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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• 00810180843133 - Shoe Cover: 2026-02-23 Shoe Cover- Universal Size, Non-Conductive, Non-Skid, 150 Pairs
• 00810180843140 - Shoe Cover: 2026-02-23 Shoe Cover, Non-Conductive and Non-Skid, XL
• 00810180843164 - Disposable BP Cuff Barrier Sleeves: 2026-02-23 Disposable BP Cuff Barrier Sleeves, Non-Woven, White, Universal
• 00810180842716 - Electrode Skin Prep Pads: 2026-02-17
• 00810180842617 - DynaLube, Lubricating Jelly Sterile, 5 g: 2026-02-04
• 00810180842600 - DynaLube, Lubricating Jelly Sterile, 2.7 g Packet: 2026-02-03
• 00840117348790 - Flavored Oral Swab, For Professional And Hospital use: 2026-01-29 Individually Wrapped