FDA.reportPublic FDA data

X-PLO2R

Primary DI
00850029991267
Brand
X-PLO2R
Company
BELLUSCURA PLC
Model
50051-US-001-RE
Device description
X-PLOR Recertified Portable Oxygen Concentrator Pkg US - 1 Battery
Published
2025-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K203086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203086000X-PLO2RBelluscura, LLC2021-03-02CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850029991267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850029991267008500299912678500299912670850029991267

GMDN Terms#

Term, Definition table
TermDefinition
Mobile/portable oxygen concentratorA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(877)-469-7567CustomerService@belluscura.com

Regulatory Flags#

DUNS number
221297691
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850029991069DISCOV-R701882025-04-18
00850029991076DISCOV-R700512025-04-18
00850029991083DISCOV-R700732025-04-18
00850029991113DISCOV-R70051-US-0012025-04-18
00850029991144DISCOV-R723912025-04-18
00850029991151DISCOV-R722912025-04-18
00850029991168DISCOV-R721912025-04-18
00850029991175DISCOV-R703512025-04-18
00850029991182DISCOV-R70051-US-0022025-04-18
00850029991199DISCOV-R70051-US-0042025-04-18
00850029991243DISCOV-R70051-US-0052025-04-18
00850029991014X-PLO2R500842025-04-17
00850029991021X-PLO2R501882025-04-17
00850029991038X-PLO2R500732025-04-17
00850029991090X-PLO2R500732025-04-17
00850029991120X-PLO2R50051-US-0012025-04-17
00850029991137X-PLO2R50051-US-0022025-04-17
00850029991205X-PLO2R503512025-04-17
00850029991212X-PLO2R521912025-04-17
00850029991229X-PLO2R522912025-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178889624Vive BreatheVIVE HEALTH LLCCAW2026-06-01
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
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
00850018761048VOCSN Patient Breathing PackageVentec Life Systems, Inc.CAW2020-10-07