WaterPAP

Primary DI
20862146000306
Brand
WaterPAP
Company
AIRWAYS DEVELOPMENT COMPANY LLC
Model
WP-7700
Device description
Positive Airway pressure device
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10862146000309PackageGS110In Commercial Distribution
20862146000306PackageGS14In Commercial Distribution
00862146000302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086214600030910862146000309
2086214600030620862146000306
00862146000302008621460003028621460003020862146000302

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
109509435
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862146000302WaterPAPWP-77002016-09-26
00862146000319WaterPAP PROWP-78002016-09-26
90862146000329WaterPAP Starter KitWP-77052016-10-03
90862146000336WaterPAP PRO Starter KitWP-78052016-10-03
40862146000300WaterPAP PROWP-78002016-09-26

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Primary DI, Brand, Company table
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10884521831636ShileyCovidien LPBYE2023-02-16
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