FDA.reportPublic FDA data

APEX

Primary DI
14713025000070
Brand
APEX
Company
APEX MEDICAL CORP.
Model
9S-005720
Device description
XT Auto
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
K112079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112079000APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720Apex Medical Corp.2012-12-06BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14713025000070PackageGS16In Commercial Distribution
04713025000073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471302500007014713025000070
04713025000073047130250000734713025000073

GMDN Terms#

Term, Definition table
TermDefinition
Home CPAP unitA portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.

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
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
14713025000087APEX9S-005720, 9S-0065002016-09-23
14713025000094APEX9S-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