FDA.report

WaterPAP Pro

Primary DI
00709078013201
Brand
WaterPAP Pro
Company
WESTMED, INC.
Model
WP-7800
Device description
WaterPAP Pro (10 devices in one box. 10 boxes in one case)
Published
2021-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BYEAttachment, Breathing, Positive End Expiratory Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10709078013208PackageGS1100In Commercial Distribution
00709078013201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907801320810709078013208
00709078013201007090780132017090780132010709078013201

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
092673953
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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20889483612009Anesthesia Circuit Kit R-60152024-05-31
20889483612016Anesthesia Circuit Kit R-66192024-05-31
20889483612023Anesthesia Circuit Kit R-68442024-05-31

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00850071887297Emergent RespiratoryMDL Solutions IncorporatedBYE2026-02-11
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07045432116090The BAG PEEP Valve 5-20 cmH2OLaerdal Medical ASBYE2026-01-14
10889483228708WaterPAP™SUNMED, LLCBYE2025-12-15
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