BiTrac Shield

GUDID 10841470107021

PULMODYNE INC

CPAP/BPAP face mask, single-use

• Primary Device ID: 10841470107021
• NIH Device Record Key: 33c25375-5e7d-4d66-be0c-bf151bce706b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiTrac Shield
• Version Model Number: 313-9050W
• 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: 317-246-5505
• Email: info@pulmodyne.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00084147107024 [Primary]
GS1	00841470107024 [Primary]
GS1	10841470107021 [Package]; Contains: 00841470107024; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023683

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-30
• Device Publish Date: 2016-10-07

Devices Manufactured by PULMODYNE INC

• 10841470100145 - O2-MAX: 2025-04-21
• 10841470105508 - BiTrac: 2025-04-21
• 10841470105515 - BiTrac: 2025-04-21
• 10841470105522 - BiTrac: 2025-04-21
• 10841470105539 - BiTrac: 2025-04-21
• 10841470105546 - BiTrac: 2025-04-21
• 10841470105553 - BiTrac: 2025-04-21
• 10841470105560 - BiTrac: 2025-04-21