Resp-O2 Vortex 72 Closed Suction Tracheal Catheter,30.5 cm/12in, 12 FR (4.0 mm)

GUDID 00840117344136

STERILE-EO, CONTENT: 1. Catheter, 1. MDI Adaptor, 1. 15 mm Swivel Adaptor, 1. 22 mm Flex Tube, 1. 15 mm x 22 mm Adaptor, 1. Trach Wedge, 1. Change of Day Sticker

Dynarex Corporation

Tracheobronchial suction/insufflation catheter, single-lumen

• Primary Device ID: 00840117344136
• NIH Device Record Key: 4fc1d4cb-d99d-45fa-b615-ed59b15eba72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Vortex 72 Closed Suction Tracheal Catheter,30.5 cm/12in, 12 FR (4.0 mm)
• Version Model Number: 31005
• 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	00840117343801 [Package]; Contains: 00840117343962; Package: Case [2 Units]; In Commercial Distribution
GS1	00840117343962 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	00840117344136 [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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