FDA.reportPublic FDA data

iQ Blue Nasal Mask with iQ StableFit Headgear

Primary DI
00814747022917
Brand
iQ Blue Nasal Mask with iQ StableFit Headgear
Company
SLEEPNET, CORP.
Model
50655-01
Device description
Nasal vented mask for use in positive pressure ventilation.
Published
2022-07-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00814747020869PreviousGS10
00814747022917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814747020869008147470208698147470208690814747020869
00814747022917008147470229178147470229170814747022917

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
785635186
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814747024850Novaplus Pediatric Nasal Vented Mask, Extra Small602222026-06-03
00814747024867Novaplus Pediatric Nasal Vented Mask, Small602232026-06-03
00814747024874Novaplus Pediatric Nasal Vented Mask, Medium602242026-06-03
00814747024881Novaplus Pediatric Nasal Vented Mask, Large602252026-06-03
00814747024898Novaplus Pediatric Nasal Non Vented Mask, Extra Small602492026-06-03
00814747024904Novaplus Pediatric Nasal Non Vented Mask, Small602502026-06-03
00814747024911Novaplus Pediatric Nasal Non Vented Mask, Medium602512026-06-03
00814747024928Novaplus Pediatric Nasal Non Vented Mask, Large602522026-06-03
00814747024751MiniMe 2 Pediatric Nasal Vented Mask, Extra Small602162026-05-06
00814747024768MiniMe 2 Pediatric Nasal Vented Mask, Small602172026-05-06
00814747024775MiniMe 2 Pediatric Nasal Vented Mask, Medium602182026-05-06
00814747024782MiniMe 2 Pediatric Nasal Vented Mask, Large602212026-05-06
00814747024799MiniMe 2 Pediatric Nasal Non Vented Mask, Extra Small602562026-05-06
00814747024805MiniMe 2 Pediatric Nasal Non Vented Mask, Small602572026-05-06
00814747024812MiniMe 2 Pediatric Nasal Non Vented Mask, Medium602582026-05-06
00814747024829MiniMe 2 Pediatric Nasal Non Vented Mask, Large602612026-05-06
00814747024676Arie Nasal Vented Mask, Small501492026-03-04
00814747024683Arie Nasal Vented Mask, Medium501502026-03-04
00814747024690Arie Nasal Vented Mask, Large501512026-03-04
00814747024706Arie Nasal Vented Mask Kit501942026-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00848530109066CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00814747024850Novaplus Pediatric Nasal Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024867Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024874Novaplus Pediatric Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024881Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03
00814747024898Novaplus Pediatric Nasal Non Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024904Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024911Novaplus Pediatric Nasal Non Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024928Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03
00848530109097CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109264CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109271CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109288CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
04719893348873WellellWellell Inc.BZD2026-06-01
09420012464668Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-19
09420012423573Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012425034Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
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09420012448446Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448514Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
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09420012456434Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464644Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464682Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18