FDA.reportPublic FDA data

APEX

Primary DI
04719893347340
Brand
APEX
Company
Wellell Inc.
Model
WiZARD 510
Device description
WiZARD 510 Nasal Mask M Size
Published
2024-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719893347340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719893347340047198933473404719893347340

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, reusableA flexible, form-shaped device designed to be placed over a user's nose 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. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656413127
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719893356434Wellell9P-0480202026-04-20
04719893356922Wellell9P-0773712026-03-20
04719893347272WellellWiZARD 5202026-03-17
04719893351026Wellell9P-0890002026-03-17
04719893347258WellellWiZARD 520 2026-03-17
04719893347265WellellWiZARD 5202026-03-17
04719893356540Wellell9P-0770002026-02-11
04719893355970Wellell9P-0775202025-10-16
04719893356007Wellell9P-0775202025-10-16
04719893356021Wellell9P-0740002025-10-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012464668Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-19
09420012423573Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012425034Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012425041Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448446Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448514Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448521Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448736Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012456434Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464644Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464682Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
04719893347272WellellWellell Inc.BZD2026-03-17
09420012461629F&P ViteraFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-01-27
09420012472212NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472229NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472236NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472243NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472366NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472373NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472380NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472397NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
08056814676223DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676247DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676254DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676261DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676377DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676384DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676391DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676407DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676230DIMARHMC PREMEDICAL SPABZD2025-03-20