FDA.reportPublic FDA data

APEX

Primary DI
14713025000773
Brand
APEX
Company
APEX MEDICAL CORP.
Model
WiZARD 310 / SM07002
Device description
Nasal Mask with Headgear (M size)
Published
2019-07-01
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
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
14713025000773PackageGS150In Commercial Distribution
04713025000776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471302500077314713025000773
04713025000776047130250007764713025000776

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
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
14713025001862APEXWiZARD 510 L size2022-07-11
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
00848530109677CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
00848530109684CPAP Mask KitSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-08-15
00198843003606Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003613Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003620Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003637Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003644Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003651Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003668Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003675Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003682Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003699Infant Flow™Zoll Medical CorporationBZD2026-08-14
06970819423212RXiBreeze PAP SystemResvent Medical Technology Co., Ltd.BZD2026-08-14
00850088881097MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881103MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881035IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881042IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881059MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881066MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881028ItAllShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-09
00198843003347Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003361Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003385Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003408Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003422Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003545Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003552Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003569Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003576Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003583Infant Flow™Zoll Medical CorporationBZD2026-06-24