FDA UDI
In Commercial Distribution
🇺🇸 United States
X-PLO2R
DI: 00850029991304
·
Model: 50051-HK-001
·
BELLUSCURA PLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- X-PLO2R
- Primary DI
- 00850029991304
- Version / Model
- 50051-HK-001
- Company Name
- BELLUSCURA PLC
- Labeler DUNS
- 221297691
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-17
- Public Version
- 1
- Public Version Date
- 2025-04-25
- Public Version Status
- New
- Public Device Record Key
- d23bff13-232c-41a2-a8e0-e9c05f72efcd
Device Description
X-PLOR Portable Oxygen Concentrator Pkg US - 1 Battery - Hong Kong
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 31321 | Mobile/portable oxygen concentrator | A mobile/portable mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is used in a home, institution, or a vehicle and typically has internal batteries for transportable use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850029991304 | GS1 |
Customer Contacts
- Phone
- (877)-469-7567
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203086 | 000 |