FDA.reportPublic FDA data

Utopia NE

Primary DI
M694UTO275A1
Brand
Utopia NE
Company
Innomed Technologies Inc
Model
LG
Catalog number
UTO275A
Device description
Utopia NE Face Mask - Large (with Black Headgear)
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M694UTO275A3PackageHIBCC5In Commercial Distribution
M694UTO275A5PackageHIBCC3In Commercial Distribution
M694UTO275A1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose and 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/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
103307950
Device count
1
Lot or batch
true
Expiration date on label
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
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
00833224000200HybridHYB523HYB5232016-09-15

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Primary DI, Brand, Company table
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