Circulaire II Aerosol Drug Delivery System

GUDID 00709078000706

with VixOne,, nose clip, mouthpiece, adult non-vented mask

WESTMED, INC.

Aerosol face mask, rebreathing
Primary Device ID00709078000706
NIH Device Record Keyc8c9e187-e85a-48ed-98c6-3fba5c2b952c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCirculaire II Aerosol Drug Delivery System
Version Model Number0395
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
GS100709078000706 [Primary]
GS110709078000703 [Package]
Package: [25 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 Number4
Public Version Date2018-07-06
Device Publish Date2016-12-11

On-Brand Devices [Circulaire II Aerosol Drug Delivery System]

10709078000796w/ Comfort Soft Plus adult non-vented mask, MiniHeart Hi-Flo, and B/V filter
10709078000789with Comfort Soft Plus adult non-vented mask, mouthpiece, B/V filter
10709078000734With extra reservoir bag, with B/V filter, 7' tubing w/threaded nut
10709078000727with extra reservoir bag, with B/V filter
00709078000706with VixOne,, nose clip, mouthpiece, adult non-vented mask
10709078000697with extra reservoir bag, violet

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