FDA.reportPublic FDA data

APEX

Primary DI
04713025000028
Brand
APEX
Company
Wellell Inc.
Model
9S-005500, 9S-006500
Device description
XT Fit with Humidifier
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062664000
K112079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062664000HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004Apex Medical Corp.2006-12-06BTT
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
14713025000025PackageGS16In Commercial Distribution
04713025000028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471302500002514713025000025
04713025000028047130250000284713025000028

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.

Regulatory Flags#

DUNS number
656413127
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719893347258WellellWiZARD 5202026-03-17
04719893347265WellellWiZARD 5202026-03-17
04719893347272WellellWiZARD 5202026-03-17
04713025000820WellellWiZARD 5102025-05-28
04713025000837WellellWiZARD 5102025-05-28
04719893348002WellellWiZARD 3102025-03-14
04719893348019WellellWiZARD 3102025-03-14
04719893348026WellellWiZARD 3102025-03-14
04719893348224WellellWiZARD 3202025-03-14
04719893348231WellellWiZARD 3202025-03-14
04719893348248WellellWiZARD 3202025-03-14
04719893348873WellellWiZARD 3302026-06-01
04719893356434Wellell9P-0480202026-04-20
04719893356922Wellell9P-0773712026-03-20
04719893351026Wellell9P-0890002026-03-17
04719893356540Wellell9P-0770002026-02-11
04719893355970Wellell9P-0775202025-10-16
04719893356007Wellell9P-0775202025-10-16
04719893356021Wellell9P-0740002025-10-16
04719893355833Wellell9P-0485602025-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344011858HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011865HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011872HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011889HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011896HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011902HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011919HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011926HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011933HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011940HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011957HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344011964HUDSON RCIMEDLINE INDUSTRIES, INC.BZD2026-08-27
10197344016884HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016891HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016938HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016945HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016969HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016976HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016983HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016990HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
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