FDA.reportPublic FDA data

APEX

Primary DI
14713025001862
Brand
APEX
Company
APEX MEDICAL CORP.
Model
WiZARD 510 L size
Device description
WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The nasal mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. The nasal mask is to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.
Published
2022-07-11
Public version status
New
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
K193206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193206000WiZARD 510 Nasal MaskApex Medical Corp.2020-10-29BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14713025001862PackageGS160In Commercial Distribution
04713025001865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471302500186214713025001862
04713025001865047130250018654713025001865

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656413127
Device count
1
DM exempt
false
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
false
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
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
14713025000094APEX9S-0065002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109042CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109059CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109066CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00814747024850Novaplus Pediatric Nasal Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024867Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024874Novaplus Pediatric Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024881Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03
00814747024898Novaplus Pediatric Nasal Non Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024904Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024911Novaplus Pediatric Nasal Non Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024928Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03
00848530109097CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109264CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109271CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109288CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
04719893348873WellellWellell Inc.BZD2026-06-01
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