BiTrac SE

GUDID 10841470106437

PULMODYNE INC

CPAP/BPAP face mask, single-use

• Primary Device ID: 10841470106437
• NIH Device Record Key: 4ee27664-b836-4689-b6a2-b31b98e9f2e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiTrac SE
• Version Model Number: 313-9012W
• 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	00841470106430 [Primary]
GS1	10841470106437 [Package]; Contains: 00841470106430; 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-25

On-Brand Devices [BiTrac SE]

• 10841470107014: 313-9009W
• 10841470106437: 313-9012W
• 10841470106420: 313-9011W
• 10841470106413: 313-9010W
• 10841470105614: 10160056
• 10841470105607: 10160055
• 10841470105591: 10160054
• 10841470105584: 10160053