BiTrac SE MaxShield

GUDID 10841470106635

PULMODYNE INC

CPAP/BPAP face mask, single-use

• Primary Device ID: 10841470106635
• NIH Device Record Key: 7e53ce2c-a603-42d1-b10c-3b94346fb2dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiTrac SE MaxShield
• Version Model Number: 313-9055W
• 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	00841470106638 [Primary]
GS1	10841470106635 [Package]; Contains: 00841470106638; 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: 2016-10-14

On-Brand Devices [BiTrac SE MaxShield]

• 10841470106994: 313-9056W
• 10841470106635: 313-9055W
• 10841470106604: 313-9053W