RUGGED OXYGEN GENERATOR (ROG)

Basic Information

• Brand Name: RUGGED OXYGEN GENERATOR (ROG)
• Primary DI: 15060031380191
• Version / Model: RO01-00001
• Company Name: MOLECULAR PRODUCTS LIMITED
• Labeler DUNS: 345709885
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-21
• Public Version: 1
• Public Version Date: 2026-04-29
• Public Version Status: New
• Public Device Record Key: 337c85dc-3474-4cdb-b0a1-a7e45cc372cb

Device Description

The Rugged Oxygen Generator (ROG) is a chemical based portable oxygen generator which generates a minimum of 96% oxygen for at least 15 minutes at a flow rate of 6 litres per minute minimum. It is a is a self-contained device with the oxygen delivered via standard oxygen mask or nasal cannula.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAW	Generator, Oxygen, Portable	Anesthesiology	868.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61062	Emergency oxygen production unit, reusable	A portable, non-electric device designed to produce medical grade oxygen, from activated chemicals, to administer to patients in first aid or emergency situations (e.g., cardiac emergencies, asthma/COPD exacerbations, shock/ trauma in the field). It consists of a reusable housing with an activation button, a single-use breathing apparatus (e.g., mask/tubing), and a replaceable single-use oxygen-generating chemical cartridge. The device is intended to be used by healthcare professionals and laypersons. This is a reusable device upon replacement of single-use components.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	25060031380198	GS1	Box	6	In Commercial Distribution
Primary	15060031380191	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K240561	000