DPM

GUDID 10841470111417

PULMODYNE INC

Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered

• Primary Device ID: 10841470111417
• NIH Device Record Key: 37329f10-e49d-43cc-8022-5e577ece108b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DPM
• Version Model Number: 313-5558
• 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	00841470111410 [Primary]
GS1	10841470111417 [Package]; Contains: 00841470111410; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003497

FDA Product Code

• CAP: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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: 2019-11-11
• Device Publish Date: 2018-03-16

On-Brand Devices [DPM]

• 10841470111417: 313-5558
• 10841470110892: 313-5559