FDA.reportPublic FDA data

APEX

Primary DI
04713025000790
Brand
APEX
Company
Wellell Inc.
Model
WiZARD 320
Device description
WiZARD 320 Full Face Mask
Published
2019-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182394000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182394000WiZARD 310/320 Series CPAP MaskApex Medical Corp.2019-05-17BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14713025000797PackageGS150In Commercial Distribution
04713025000790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471302500079714713025000797
04713025000790047130250007904713025000790

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
656413127
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719893347258WellellWiZARD 5202026-03-17
04719893347265WellellWiZARD 5202026-03-17
04719893347272WellellWiZARD 5202026-03-17
04713025000820WellellWiZARD 5102025-05-28
04713025000837WellellWiZARD 5102025-05-28
04719893348002WellellWiZARD 3102025-03-14
04719893348019WellellWiZARD 3102025-03-14
04719893348026WellellWiZARD 3102025-03-14
04719893348224WellellWiZARD 3202025-03-14
04719893348231WellellWiZARD 3202025-03-14
04719893348248WellellWiZARD 3202025-03-14
04719893348873WellellWiZARD 3302026-06-01
04719893356434Wellell9P-0480202026-04-20
04719893356922Wellell9P-0773712026-03-20
04719893351026Wellell9P-0890002026-03-17
04719893356540Wellell9P-0770002026-02-11
04719893355970Wellell9P-0775202025-10-16
04719893356007Wellell9P-0775202025-10-16
04719893356021Wellell9P-0740002025-10-16
04719893355833Wellell9P-0485602025-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197344011889HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011896HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011902HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011919HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011926HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011933HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011940HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011957HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011964HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
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00848530109684CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
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00198843003682Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003699Infant Flow™Zoll Medical CorporationBZD2026-08-14
06970819423212RXiBreeze PAP SystemResvent Medical Technology Co., Ltd.BZD2026-08-14
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