VixOne

GUDID 10709078000451

Small Volume Nebulizer

WESTMED, INC.

Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use
Primary Device ID10709078000451
NIH Device Record Keyd329853e-5f2f-4628-9538-c3fd7210f04e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVixOne
Version Model Number0218
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100709078000454 [Primary]
GS110709078000451 [Package]
Contains: 00709078000454
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

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 Date2016-11-24

On-Brand Devices [VixOne]

00709078002359VixOne Nebulizer Bulk(325/Cs)
10709078002332VixOne, Infant Nebulizer Kit
10709078002325VixOne Infant Inline Nebulizer Kit W/15mm Tee
10709078001687Nebulizer Composite Kit
10709078000499Small Volume Nebulizer
10709078000482Small Volume Nebulizer
10709078000475Small Volume Nebulizer
10709078000468Small Volume Nebulizer
10709078000451Small Volume Nebulizer
10709078000444Small Volume Nebulizer
10709078000437Small Volume Nebulizer
10709078000420Small Volume Nebulizer
10709078000413Small Volume Nebulizer
10709078000406Small Volume Nebulizer
10709078000390Small Volume Nebulizer

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