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

• 00840117340336 - Resp-O2 Nebulizer Tee Connector, Standard 22 mm x OD x 18 mm ID x 22 mm OD: 2025-10-07 Connections
• 00840117340428 - Resp-O2 Disposable Guedel Airway, 120 mm, Adult XX-Large, Lavender: 2025-10-07
• 00616784150529 - Adhesive Tape Remover Pads, For Professional and Hospital Use: 2025-10-06
• 00810180842303 - Dynarex Skincote Protective Dressing Applicators, 1.25" x 2.68": 2025-10-06 (3.25 cm x 6.81 cm)
• 00616784191027 - DynaFit Graduated Compression Anti-Embolism Stocking,Small: 2025-10-06 Knee Moderate (15-20 MMHG) Compression
• 00616784191119 - DynaFit Graduated Compression Anti-Embolism Stocking, Medium Knee: 2025-10-06
• 00616784191218 - DynaFit Graduated Compression Anti-Embolism Stocking, Large Knee: 2025-10-06
• 00616784191317 - DynaFit Graduated Compression Anti-Embolism Stocking, X-Large Knee: 2025-10-06