POGS

GUDID 00860001899009

The Portable Oxygen Generator System 33 (POGS 33C) has been designed to accommodate medical personnel with a source of supplemental oxygen in a setting where liquid oxygen may be unavailable, and of medical air to drive respiratory equipment.

ON SITE GAS SYSTEMS, INC.

Portable oxygen concentrator

• Primary Device ID: 00860001899009
• NIH Device Record Key: bd1f5670-a0a1-4a54-9069-c81813805b60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POGS
• Version Model Number: POGS33C
• Company DUNS: 195055769
• Company Name: ON SITE GAS SYSTEMS, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	00860001899009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063454

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: 2019-06-27
• Device Publish Date: 2019-06-19

On-Brand Devices [POGS]

• 00860001899016: The On Site Gas Systems portable oxygen generator is a prescription device designed to provide a
• 00860001899009: The Portable Oxygen Generator System 33 (POGS 33C) has been designed to accommodate medical pers