FDA.reportPublic FDA data

Nasal-Aire II

Primary DI
00833224006103
Brand
Nasal-Aire II
Company
Innomed Technologies Inc
Model
PE415
Catalog number
PE415
Device description
Nasal-Aire II Petite Cannula - Size E
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
30833224006104PackageGS114In Commercial Distribution
50833224006108PackageGS18In Commercial Distribution
00833224006103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3083322400610430833224006104
5083322400610850833224006108
00833224006103008332240061038332240061030833224006103

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, reusableA flexible, form-shaped device designed to be placed over a user's nose 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. 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
00833224000163HybridHYB515HYB5152016-09-15
00833224000170HybridHYB513HYB5132016-09-15
00833224000187HybridHYB511HYB5112016-09-15
00833224000194HybridHYB525HYB5252016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00198843003590Infant Flow™Zoll Medical CorporationBZD2026-06-24
00814747024935MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024942MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024959MiniMe 2 Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024966MiniMe 2 Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024973Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024980Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024997Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747025000Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
04048675824121Seattle PAPDrägerwerk AG & Co. KGaABZD2026-06-11
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109042CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109059CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04