Rapid Oxygen R15
Basic Information
- Brand Name
- Rapid Oxygen R15
- Primary DI
- 10860466001808
- Version / Model
- R15
- Company Name
- RAPID OXYGEN INC
- Labeler DUNS
- 098894592
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-03
- Public Version
- 1
- Public Version Date
- 2019-01-03
- Public Version Status
- New
- Public Device Record Key
- 0dc261e7-3d6f-49f2-8fec-2bac16042ccc
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.
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 |
|---|---|---|---|---|
| 62988 | Emergency oxygen production unit, single-use | 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 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10860466001808 | GS1 |
Customer Contacts
- Phone
- 203-989-9065
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033863 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 104 Degrees Fahrenheit