FDA.reportPublic FDA data

WaterPAP PRO

Primary DI
00862146000319
Brand
WaterPAP PRO
Company
AIRWAYS DEVELOPMENT COMPANY LLC
Model
WP-7800
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30862146000303PackageGS110In Commercial Distribution
40862146000300PackageGS14In Commercial Distribution
00862146000319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3086214600030330862146000303
4086214600030040862146000300
00862146000319008621460003198621460003190862146000319

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical expiratory valve, single-useA non-sterile mechanical device intended to be used in a respiratory or anaesthesia breathing circuit or system to maintain a degree of positive pressure in a patient's airway at the end of expiration. Typically constructed of plastic/metal it has a valve that is actuated by a spring to provide expiratory airway resistance, and an adjustable knob (usually not graduated) that is typically set between 0 and 20 cmH20 pressure, but may be fully closed when controlled/assisted ventilation is applied. It is normally used with anaesthesia breathing systems, pulmonary resuscitators, or ventilators and is commonly known as a pop-off valve, relief valve, or spill valve. This is a single-use device.

Regulatory Flags#

DUNS number
109509435
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862146000302WaterPAPWP-77002016-09-26
90862146000329WaterPAP Starter KitWP-77052016-10-03
90862146000336WaterPAP PRO Starter KitWP-78052016-10-03
20862146000306WaterPAPWP-77002016-09-26
40862146000300WaterPAP PROWP-78002016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810094578046Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00026072001479EMAllied Medical, LLCBYE2024-05-28
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00810094575014CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
10884521831643ShileyCovidien LPBYE2023-02-18
10884521831636ShileyCovidien LPBYE2023-02-16
00810071637261CuraplexBOUND TREE MEDICAL, LLCBYE2022-12-30
00810071637278CuraplexBOUND TREE MEDICAL, LLCBYE2022-12-30
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10190752133181AirLife™AIRLIFEBYE2020-01-15