FDA.reportPublic FDA data

APEX

Primary DI
14713025000605
Brand
APEX
Company
APEX MEDICAL CORP.
Model
WiZARD 220
Device description
Full Face Mask with Headgear (SW)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K103174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103174000APEX MEDICAL WIZARD SERIES CPAP MASKApex Medical Corp.2011-05-06BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14713025000605PackageGS150In Commercial Distribution
04713025000608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471302500060514713025000605
04713025000608047130250006084713025000608

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14713025001862APEXWiZARD 510 L size2022-07-11
14713025000773APEXWiZARD 310 / SM070022019-07-01
14713025000780APEXWiZARD 310 / SM070032019-07-01
14713025000797APEXWiZARD 320 / SM080012019-07-01
14713025000803APEXWiZARD 320 / SM080022019-07-01
14713025000810APEXWiZARD 320 / SM080032019-07-01
14713025002050APEXDomus 1 with 2.5" Bubble Pad2018-07-04
14713025002487APEXDomus 2s with 5" One Piece Pad2018-07-04
14713025002807APEXSerene with 8"+2" Mattress2018-07-04
14713025003132APEXSedens 500 Dynamics with 4" Cushion2018-07-04
14713025004337APEXDomus 3 with 8" Mattress2018-07-04
14713025004351APEXDomus 3 with 5"+3" Mattress2018-07-04
14713025004368APEXSerene Bariatric with 8"+2" Mattress2018-07-04
14713025004382APEXSerene Elite with 8" Mattress2018-07-04
14713025000025APEX9S-005500, 9S-0065002016-09-23
14713025000049APEX9S-005530, 9S-0065002016-09-23
14713025000056APEX9S-0055802016-09-23
14713025000063APEX9S-005580, 9S-0065002016-09-23
14713025000070APEX9S-0057202016-09-23
14713025000087APEX9S-005720, 9S-0065002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530106461CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106478CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106485CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106492CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106508CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106515CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-17
00848530106355CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106362Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106379CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106386CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106393CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106409Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
10889483586358Vital Signs™AIRLIFEBZD2025-02-18
00848530081638CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530085230CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090661CPAP MaskSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090678CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090685CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090692CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090708CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090715CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090722CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090739CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090746CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097103CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097110CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097127CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097134CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097141CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097158CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29