FDA.reportPublic FDA data

Rugged Oxygen Generator (ROG)

Primary DI
05060031380002
Brand
Rugged Oxygen Generator (ROG)
Company
MOLECULAR PRODUCTS LIMITED
Model
EO209P63N29
Device description
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 self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAWGenerator, Oxygen, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAWGenerator, Oxygen, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131016000ROGSMolecular Products , Ltd.2013-11-27CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060031380019PackageGS16In Commercial Distribution
05060031380002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060031380019050600313800195060031380019
05060031380002050600313800025060031380002

GMDN Terms#

Term, Definition table
TermDefinition
Emergency oxygen production unit, reusableA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+4401279445111sales@molprod.com

Regulatory Flags#

DUNS number
345709885
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060031380191RUGGED OXYGEN GENERATOR (ROG)RO01-000012026-04-21
05060031380019Rugged Oxygen Generator (ROG)EO209P63N292016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885304034834DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00885304034841DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00885304034858DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00860007698262MOSTPacific Consolidated Industries LLCCAW2026-05-06
06934726614316LongfianLongfian Scitech Co., Ltd.CAW2026-05-04
00810178885756ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885763ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885770ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885787ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885794ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885800ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885817ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885824ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00850083102944Rhythm Healthcare, LLCRhythm Healthcare, LLCCAW2026-04-24
00850083102319Rhythm HealthcareRhythm Healthcare, LLCCAW2026-04-22
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
06933257948488YUWELL Portable Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2026-02-24
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-12-02
06953077101160Oxygen concentratorShenyang Canta Medical Tech.Co.,LtdCAW2025-10-08
06953077101177Oxygen concentratorShenyang Canta Medical Tech.Co.,LtdCAW2025-10-08
M766AS200SW460AryaCAIRE INC.CAW2025-08-13
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-08-06
06933257921856YUWELL Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2024-01-09
10840330700396ProcureTwin Med, LLCCAW2022-11-03
M766AS200SW6AryaCAIRE INC.CAW2022-05-26
00855573007761VOCSNVentec Life Systems, Inc.CAW2022-04-12
00709078014062InLine Water TrapWESTMED, INC.CAW2022-03-31
00850018761178VOCSN Power SupplyVentec Life Systems, Inc.CAW2022-03-23
00850018761130VOCSNVentec Life Systems, Inc.CAW2021-03-03