Bubble Humidifier

GUDID 00709078003158

Bubble Humidifier, Dry, High Flow

WESTMED, INC.

Non-heated respiratory humidifier Non-heated respiratory humidifier
Primary Device ID00709078003158
NIH Device Record Key8b36eff2-fbbf-473f-8713-49125500781c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBubble Humidifier
Version Model Number0795
Company DUNS092673953
Company NameWESTMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100709078003158 [Primary]

FDA Product Code

KFZHumidifier, Non-Direct Patient Interface (Home-Use)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-26

On-Brand Devices [Bubble Humidifier]

00709078003158Bubble Humidifier, Dry, High Flow
10709078007603Bubble Humidifier, Dry
10709078014281Concentrator Bubble Humidifier Elbow Adaptor
10709078014274DRY BUBBLE HUMIDIFIER LOW FLOW Up To 6 LPM
10709078014090DRY BUBBLE HUMIDIFIER HIGH FLOW 6 - 20 LPM

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