FDA.reportPublic FDA data

Whisperflow CPAP Valve

Primary DI
00884838083301
Brand
Whisperflow CPAP Valve
Company
Respironics Novametrix, LLC
Model
00
Catalog number
8-209507-00
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYEAttachment, breathing, positive end expiratory pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950397000SYSTEM 22 VALVETurnkey Intergration USA, Inc.1995-04-14BYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884838083302PackageGS110In Commercial Distribution
00884838083301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088483808330230884838083302
00884838083301008848380833018848380833010884838083301

GMDN Terms#

Term, Definition table
TermDefinition
PEEP valve, single-useA non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(724)744-2500respironics.service@philips.com

Regulatory Flags#

DUNS number
093608594
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838104723Airway Adapters114946611494662023-11-15
00884838104730Airway Adapters114933911493392023-11-15
00884838104761Airway Adapters114938111493812023-11-15
00884838104778Airway Adapter114938311493832023-11-15
00884838104785Airway Adapters114938611493862023-11-15
00884838104792Airway Adapters114944811494482023-11-15
00884838104884LoFlo Accessories114948011494802023-11-15
00884838104891LoFlo Accessories114948211494822023-11-15
00884838104907LoFlo Accessories114948311494832023-11-15
00884838104938LoFlo Accessories114937911493792023-11-15
00884838104945LoFlo Accessories114948811494882023-11-15
00884838104952Airway Adapters114948911494892023-11-15
00884838104969Airway Adapters114949011494902023-11-15
00884838104976Airway Adapters114949111494912023-11-15
00884838104983Airway Adapters114949211494922023-11-15
00884838105584Flow Sensor114990311499032023-11-15
00884838105607Flow Sensor114990511499052023-11-15
00884838105614Airway Adapters114994811499482023-11-15
00884838105621Airway Adapters114994211499422023-11-15
00884838104662Capnostat 5 114932111493212023-11-14

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