FDA.report

Wellell

Primary DI
04719893347272
Company
Wellell Inc.
Model
WiZARD 520
Device description
WiZARD 520 Full Face Mask (S size)
Published
2026-03-17
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
656413127
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
04719893347272PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
04719893347272PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
BZDVentilator, Non-Continuous (Respirator)2Anesthesiology868.5905NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
CPAP/BPAP face mask, reusableA flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04719893356922Wellell9P-0773712026-03-20
04719893347258WellellWiZARD 520 2026-03-17
04719893347265WellellWiZARD 5202026-03-17
04719893351026Wellell9P-0890002026-03-17
04719893356540Wellell9P-0770002026-02-11
04719893355833Wellell9P-0485602025-09-19
04719893355857Wellell9P-0485602025-09-19
04719893355871Wellell 9P-0775202025-09-19
04719893355901Wellell9P-0470002025-09-19
04719893355925Wellell9P-0470002025-09-19
04719893355574Wellell9P-0485602025-08-13
04713025000820WellellWiZARD 5102025-05-28
04713025000837WellellWiZARD 5102025-05-28
04719893311877Wellell9P-0775202025-05-28
04719893311884Wellell9P-0770002025-05-28
04719893311945Wellell9P-0470002025-05-28
04719893311952Wellell9P-0470002025-05-28
04719893354331Wellell9P-0470002025-05-28
04719893354690Wellell9P-0790002025-05-21
04719893354713Wellell 9P-0775202025-05-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
09420012464699Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-19
04719893347258WellellWellell Inc.BZD2026-03-17
04719893347265WellellWellell Inc.BZD2026-03-17
24710810084946N/AGALEMED CORPORATIONBZD2026-03-05
44710810089747N/AGALEMED CORPORATIONBZD2026-03-05
44710810115620N/AGALEMED CORPORATIONBZD2026-03-05
44710810115637N/AGALEMED CORPORATIONBZD2026-03-05
44710810109636N/AGALEMED CORPORATIONBZD2026-03-05
44710810109643N/AGALEMED CORPORATIONBZD2026-03-05
44710810109650N/AGALEMED CORPORATIONBZD2026-03-05
44710810119666N/AGALEMED CORPORATIONBZD2026-03-05
44710810110175N/AGALEMED CORPORATIONBZD2026-03-05
44710810112452N/AGALEMED CORPORATIONBZD2026-03-05
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00814747024737Arie Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-03-04
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