Healthcare Logistics Systems

GUDID 00817698020698

HEALTHCARE LOGISTICS SYSTEMS LLC

Mobile/portable oxygen concentrator

• Primary Device ID: 00817698020698
• NIH Device Record Key: d468bdc9-9e6c-4ce4-83f0-95d7434efd4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healthcare Logistics Systems
• Version Model Number: 8050
• Company DUNS: 079452927
• Company Name: HEALTHCARE LOGISTICS SYSTEMS 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: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817698020698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202389

FDA Product Code

• CAW: Generator, Oxygen, Portable

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: 2025-05-09
• Device Publish Date: 2025-05-01

On-Brand Devices [Healthcare Logistics Systems]

• 00817698020711: 1250
• 00817698020704: 1550
• 00817698020698: 8050