FDA UDI
In Commercial Distribution
🇺🇸 United States
Rugged Oxygen Generator (ROG)
DI: 05060031380002
·
Model: EO209P63N29
·
MOLECULAR PRODUCTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Rugged Oxygen Generator (ROG)
- Primary DI
- 05060031380002
- Version / Model
- EO209P63N29
- Company Name
- MOLECULAR PRODUCTS LIMITED
- Labeler DUNS
- 345709885
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- cf33c996-f360-46f8-a3f6-51b740ea834b
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.
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
- No
- 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 | 05060031380019 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 05060031380002 | GS1 |
Customer Contacts
- Phone
- +4401279445111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131016 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius