Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 10 FR (3.3 mm),30.5 cm/12 in

GUDID 00840117344167

Double Swivel Elbow (DSE), Tracheal, Adult/Pediatric CONTENTS: 1. Closed Suction Catheter (Adult/Pediatric), 1. MDI Adaptor, 1. 15 mm x 22 mm Flex Tube, 1. Trach Wedge 1. Change of Day Sticker

Dynarex Corporation

Tracheobronchial suction/insufflation catheter, single-lumen

• Primary Device ID: 00840117344167
• NIH Device Record Key: abb8f561-8b1b-4f1a-8e93-eca579306cb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 10 FR (3.3 mm),30.5 cm/12 in
• Version Model Number: 31014
• Company DUNS: 008124539
• Company Name: Dynarex Corporation
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117343832 [Package]; Contains: 00840117343993; Package: Case [2 Units]; In Commercial Distribution
GS1	00840117343993 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	00840117344167 [Primary]

FDA Product Code

• BSY: Catheters, Suction, Tracheobronchial

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: 2026-01-13
• Device Publish Date: 2026-01-05

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