VixOne Nebulizer

GUDID 00709078000676

Bulk Packaged

WESTMED, INC.

Nebulizing system delivery set, single-use
Primary Device ID00709078000676
NIH Device Record Keybd4b28f5-0beb-4452-adee-109ba35af4c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameVixOne Nebulizer
Version Model Number0244
Company DUNS092673953
Company NameWESTMED, INC.
Device Count300
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
GS100709078000676 [Primary]
GS100709078002120 [Unit of Use]

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 Date2016-12-10

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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