Rapid Oxygen R15

Primary DI
10860466001808
Brand
Rapid Oxygen R15
Company
RAPID OXYGEN INC
Model
R15
Device description
The R-15 oxygen generator provides on-demand oxygen delivered to the subject using an oxygen facemask. The R-15 oxygen generator consists of housing containing the oxygen generating chemical in mesh pouches, reaction regulating sealed liquid containing pouches, a lid, a water bag and a valve assembly with a compartment for the catalyst. The oxygen producing chemical, catalyst and water are isolated from each other during storage by placing each in separated sealed compartments. The compartments are connected by a valve that upon activation allows the water to flow through a chamber in the valve containing the catalyst and into the compartment in the housing with the mixture. The water distributes the catalyst through the compartment and submerses the oxygen generating chemical mixture and a portion of the sealed pouches. When the hydrogen peroxide contacts MnO2, the hydrogen peroxide is decomposed catalytically to water and oxygen.
Published
2018-12-03
Public version status
New
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
K033863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033863000OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03Ox-Gen, Inc.2005-08-22CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860466001808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086046600180810860466001808

GMDN Terms#

Term, Definition table
TermDefinition
Emergency oxygen production unit, single-useA 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 main housing with an oxygen-generating chemical core, a spring-loaded initiation mechanism, and a breathing apparatus (e.g., mouthpiece or mask/tubing). The device is intended to be used by healthcare professionals and laypersons. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature40 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
203-989-9065support@rapidoxygen.com

Regulatory Flags#

DUNS number
098894592
Device count
1
Lot or batch
true
Expiration date on label
true

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