FDA.reportPublic FDA data

APEX

Primary DI
14713025000100
Brand
APEX
Company
APEX MEDICAL CORP.
Model
9S-007201
Device description
iCH 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
K150111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150111000Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp.2015-09-15BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14713025000100PackageGS16In Commercial Distribution
04713025000103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471302500010014713025000100
04713025000103047130250001034713025000103

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
14713025000070APEX9S-0057202016-09-23
14713025000087APEX9S-005720, 9S-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
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00198843003644Infant Flow™Zoll Medical CorporationBZD2026-08-14
00198843003651Infant Flow™Zoll Medical CorporationBZD2026-08-14
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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