WaterPAP PRO Starter Kit

GUDID 90862146000336

WaterPAP PRO Starter Kit consists of 4 WaterPAP PRO Canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole Clamp, Instructions for use.

AIRWAYS DEVELOPMENT COMPANY LLC

Mechanical expiratory valve, single-use
Primary Device ID90862146000336
NIH Device Record Keycf393c32-d31e-4c5c-81bc-f6973062fa95
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaterPAP PRO Starter Kit
Version Model NumberWP-7805
Company DUNS109509435
Company NameAIRWAYS DEVELOPMENT COMPANY LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS190862146000336 [Primary]

FDA Product Code

BYEAttachment, Breathing, Positive End Expiratory Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-05
Device Publish Date2016-10-03

Devices Manufactured by AIRWAYS DEVELOPMENT COMPANY LLC

90862146000329 - WaterPAP Starter Kit2018-11-05 WaterPAP Starter Kit consists of 4 WaterPAP canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole clamp, Instructions for
90862146000336 - WaterPAP PRO Starter Kit2018-11-05WaterPAP PRO Starter Kit consists of 4 WaterPAP PRO Canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole Clamp, Instructions for use.
90862146000336 - WaterPAP PRO Starter Kit2018-11-05 WaterPAP PRO Starter Kit consists of 4 WaterPAP PRO Canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole Clamp, Instructi
20862146000306 - WaterPAP2018-11-05 Positive Airway pressure device
40862146000300 - WaterPAP PRO2018-11-05

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