Discov-R

FDA UDI

Class II (US FDA UDI)

by Belluscura Plc

Identity

Trade Name: DISCOV-R FDA UDI
Generic Name: Mobile/portable oxygen concentrator FDA UDI
Device Name: DISCOV-R Battery FDA UDI
Model / Reference: 70188 FDA UDI
Description: DISCOV-R Battery FDA UDI

Identifiers

Primary DI / UDI-DI: 00850029991069 FDA UDI
510(k) Number: K203086 FDA UDI
FDA Product Code: CAW FDA UDI
GMDN Term: Mobile/portable oxygen concentrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5440 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Mobile/portable oxygen concentrator

Discov-R by Belluscura Plc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Mobile/portable oxygen concentrator.

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SimplyGo Mini — Respironics, Inc. · Class II
SimplyGo Mini — Respironics, Inc. · Class II
FreeStyle — CAIRE INC. · Class II
Invacare Panel Control for PerfectO2 and PerfectO2V — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
GCE — GAS CONTROL EQUIPMENT LIMITED · Class II
SimplyGo Mini — Respironics, Inc. · Class II

Cleared under the same submission

K203086 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Belluscura Plc

Sources (1)

FDA UDI 91ba03ae-d2c5-4f49-aa42-7f7a4fb10c7a 35 fields · synced May 30, 2026