Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR

GUDID 00840117322974

DYNAREX CORPORATION

Endotracheal tube introducer, single-use

• Primary Device ID: 00840117322974
• NIH Device Record Key: 416584d1-6477-4cf2-afa8-518d718b539c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR
• Version Model Number: 36260
• 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	00840117313347 [Primary]
GS1	00840117313354 [Package]; Contains: 00840117313347; Package: Shipper [20 Units]; In Commercial Distribution
GS1	00840117322974 [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: 2022-05-25
• Device Publish Date: 2022-05-17

On-Brand Devices [Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR]

• 00840117322974: 36260
• 08401173133472: 36260
• 00810180840019: 36260