TrachVox

GUDID 10841470101098

PULMODYNE INC

Heat/moisture exchanger, single-use

• Primary Device ID: 10841470101098
• NIH Device Record Key: 7134b696-cd52-46fe-9cd1-f8f0cb7f98df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrachVox
• Version Model Number: 313-1000
• Company DUNS: 030619483
• Company Name: PULMODYNE INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 337-246-5500
• Email: info@pulmodyne.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470101091 [Primary]
GS1	10841470101098 [Package]; Contains: 00841470101091; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013728

FDA Product Code

• JOH: Tube Tracheostomy And Tube Cuff

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-11

Devices Manufactured by PULMODYNE INC

• 10841470105454 - HMEF: 2024-07-09
• 10841470105461 - HMEF: 2024-07-09
• 10841470105478 - HMEF: 2024-07-09
• 10841470105485 - HMEF: 2024-07-09
• 10841470100718 - VT Select: 2023-04-18
• 10841470100749 - VT Select: 2023-04-18
• 10841470100770 - VT Select: 2023-04-18
• 10841470100794 - VT Select: 2023-04-18