ADAPT-2-VENT

GUDID 10841470111769

PULMODYNE INC

CPAP/BPAP face mask, single-use

• Primary Device ID: 10841470111769
• NIH Device Record Key: 81b8981c-7f18-4060-878d-9b175aaa120b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAPT-2-VENT
• Version Model Number: 313-7030S
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470111762 [Primary]
GS1	10841470111769 [Package]; Contains: 00841470111762; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-28
• Device Publish Date: 2018-12-28

On-Brand Devices [ADAPT-2-VENT]

• 10841470111769: 313-7030S
• 10841470111615: 313-7029C