FDA.reportPublic FDA data

Hybrid

Primary DI
00833224000163
Brand
Hybrid
Company
Innomed Technologies Inc
Model
HYB515
Catalog number
HYB515
Device description
Hybrid Cushion- LG
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50833224000168PackageGS132In Commercial Distribution
00833224000163PrimaryGS10
M694HYB5151SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5083322400016850833224000168
00833224000163008332240001638332240001630833224000163

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP oral maskA flexible, form-shaped device designed to be fitted to the user's 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 patient's mouth; this providing a solution for mouth breathers and patients with chronic nasal obstruction. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
800-200-9842customerservice@innomedinc.com

Regulatory Flags#

DUNS number
103307950
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M694HYB5711Hybrid NESMHYB5712015-10-24
M694HYB5731Hybrid NEMDHYB5732015-10-24
M694HYB5751Hybrid NELGHYB5752015-10-24
M694HYB5911Hybrid HVSMHYB5912015-10-24
M694HYB5931Hybrid HVMDHYB5932015-10-24
M694HYB5951Hybrid HVLGHYB5952015-10-24
M694UTO2711Utopia NESMUTO2712015-10-24
M694UTO271A1Utopia NESMUTO271A2015-10-24
M694UTO2731Utopia NEMDUTO2732015-10-24
M694UTO273A1Utopia NEMDUTO273A2015-10-24
M694UTO2751Utopia NELGUTO2752015-10-24
M694UTO275A1Utopia NELGUTO275A2015-10-24
M694UTO2911Utopia HVSMUTO2912015-10-24
M694UTO2931Utopia HVMDUTO2932015-10-24
M694UTO2951Utopia HVLGUTO2952015-10-24
00833224000156HybridHYB500HYB5002016-09-15
00833224000170HybridHYB513HYB5132016-09-15
00833224000187HybridHYB511HYB5112016-09-15
00833224000194HybridHYB525HYB5252016-09-15
00833224000200HybridHYB523HYB5232016-09-15

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
00848530106522CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-17
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
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