VIBRALUNG®

GUDID 00709078002403

Demo User Kit with Travel Bag, VIBRALUNG®

WESTMED, INC.

Electroacoustical airway secretion-clearing system
Primary Device ID00709078002403
NIH Device Record Key1998b865-074b-4035-9f70-eb17152ee6f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIBRALUNG®
Version Model Number9501D
Company DUNS092673953
Company NameWESTMED, INC.
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100709078002403 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYIPercussor, Powered-Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-17

On-Brand Devices [VIBRALUNG®]

10709078002417VIBRALUNG® HHT Hanger
00709078002403Demo User Kit with Travel Bag, VIBRALUNG®
00709078002397Demo Treatment Control Unit Assembly, VIBRALUNG® Acoustical

Trademark Results [VIBRALUNG]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VIBRALUNG
VIBRALUNG
78405637 3389688 Live/Registered
VibraLung, Inc.
2004-04-21

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