X-PLO2R

GUDID 00850029991304

X-PLOR Portable Oxygen Concentrator Pkg US - 1 Battery - Hong Kong

BELLUSCURA PLC

Mobile/portable oxygen concentrator

• Primary Device ID: 00850029991304
• NIH Device Record Key: d23bff13-232c-41a2-a8e0-e9c05f72efcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-PLO2R
• Version Model Number: 50051-HK-001
• Company DUNS: 221297691
• Company Name: BELLUSCURA PLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (877)-469-7567
• Email: CustomerService@belluscura.com
• Phone: (877)-469-7567
• Email: CustomerService@belluscura.com
• Phone: (877)-469-7567
• Email: CustomerService@belluscura.com
• Phone: (877)-469-7567
• Email: CustomerService@belluscura.com
• Phone: (877)-469-7567
• Email: CustomerService@belluscura.com
• Phone: (877)-469-7567
• Email: CustomerService@belluscura.com
• Phone: (877)-469-7567
• Email: CustomerService@belluscura.com
• Phone: (877)-469-7567
• Email: CustomerService@belluscura.com
• Phone: (877)-469-7567
• Email: CustomerService@belluscura.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850029991304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203086

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-25
• Device Publish Date: 2025-04-17

On-Brand Devices [X-PLO2R]

• 00850029991007: Portable oxygen concentrator
• 00850029991304: X-PLOR Portable Oxygen Concentrator Pkg US - 1 Battery - Hong Kong
• 00850029991298: X-PLOR Portable Oxygen Concentrator Pkg US - 2 Batteries - 5 Setting
• 00850029991281: X-PLOR Portable Oxygen Concentrator Pkg US - 1 Battery - 5 Setting
• 00850029991274: X-PLOR Recertified Portable Oxygen Concentrator Pkg US - 2 Batteries
• 00850029991267: X-PLOR Recertified Portable Oxygen Concentrator Pkg US - 1 Battery
• 00850029991250: X-PLOR Portable Oxygen Concentrator - Recertified
• 00850029991236: X-PLOR Portable Oxygen Concentrator Pkg US + 3 Batteries
• 00850029991229: X-PLOR Backpack
• 00850029991212: X-PLOR Carry Bag & Straps
• 00850029991205: Exhaust Filter
• 00850029991137: X-PLOR Portable Oxygen Concentrator Pkg US + 2 Batteries
• 00850029991120: X-PLOR Portable Oxygen Concentrator Pkg US - 1 Battery
• 00850029991090: X-PLOR Sieve Cartridge - Aluminum
• 00850029991038: X-PLOR Sieve Cartridge
• 00850029991021: X-PLOR Eight-Cell Battery
• 00850029991014: X-PLOR Four-Cell Battery