Rugged Oxygen Generator (ROG)

GUDID 05060031380019

The ROG is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 Lpm. It is a sel

MOLECULAR PRODUCTS LIMITED

Emergency oxygen production unit, reusable

• Primary Device ID: 05060031380019
• NIH Device Record Key: cf33c996-f360-46f8-a3f6-51b740ea834b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rugged Oxygen Generator (ROG)
• Version Model Number: EO209P63N29
• Company DUNS: 345709885
• Company Name: MOLECULAR PRODUCTS LIMITED
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +4401279445111
• Email: sales@molprod.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060031380002 [Primary]
GS1	05060031380019 [Package]; Contains: 05060031380002; Package: Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131016

FDA Product Code

• CAW: Generator, Oxygen, Portable

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: 2018-07-06
• Device Publish Date: 2016-09-26