VixOne Nebulizer

GUDID 10709078004954

VixOne Nebulizer w/ Adult Elongated Mask

WESTMED, INC.

Nebulizing system delivery set, reusable
Primary Device ID10709078004954
NIH Device Record Keye1a88443-c5a4-49e5-9a0e-4055a577a60c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVixOne Nebulizer
Version Model Number0327
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
GS100709078004957 [Primary]
GS110709078004954 [Package]
Contains: 00709078004957
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 Date2017-10-20

On-Brand Devices [VixOne Nebulizer]

10709078006194VixOne Nebulizer 7' Tubing
10709078004961VixOne Nebulizer w/ Pediatric Elongated Mask
10709078004954VixOne Nebulizer w/ Adult Elongated Mask
00709078001574Bulk packaged
00709078000676Bulk Packaged

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