NAPA LP-15

GUDID 00860898002650

Airway Pressure Monitor

DRW MEDICAL LLC

Airway pressure monitor, powered

• Primary Device ID: 00860898002650
• NIH Device Record Key: 2d35f680-e607-46cc-ae7c-fd8da3a41d5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAPA
• Version Model Number: Airway Pressure Monitor
• Catalog Number: LP-15
• Company DUNS: 080686360
• Company Name: DRW MEDICAL LLC
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860898002643 [Primary]
GS1	00860898002650 [Package]; Contains: 00860898002643; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172284

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-03
• Device Publish Date: 2018-12-03

On-Brand Devices [NAPA]

• 00860898002650: Airway Pressure Monitor
• 10860898002633: Sample Line Kit
• 00860898002629: Power Supply
• 00860898002612: Pole Mounting Clamp
• 00860898002605: Bracket