VixOne™ Reusable Nebulizer

GUDID 10709078004862

1 reusable Vixone Super Spike Mask, 7' tubing, Pedi-Neb, nebulizer compressor

WESTMED, INC.

Nebulizing system delivery set, reusable Nebulizing system delivery set, reusable
Primary Device ID10709078004862
NIH Device Record Key21f3877a-a913-49b4-bde4-3a412e598c81
Commercial Distribution StatusIn Commercial Distribution
Brand NameVixOne™ Reusable Nebulizer
Version Model Number0397
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 Kittrue
Device Combination Productfalse
Single Usefalse
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
GS100709078004865 [Primary]
GS110709078004862 [Package]
Contains: 00709078004865
Package: [1 Units]
In Commercial Distribution

FDA Product Code

OGGHumidifier Nebulizer Kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-06-19
Device Publish Date2017-08-31

Devices Manufactured by WESTMED, INC.

10709078006200 - Anesthesia Circuit Kit 2024-02-15 96" expandable dual limb circuit patient elbow with capped sampling port in-line mini HMEF with sample port Size 6 large adult m
10709078007665 - Uni-Lim Coaxial Circuit2024-02-15 Uni-Lim Coaxial Circuit 48" Expandable Anesthesia Extension Kit
30889483608955 - Anesthesia Circuit Kit 2023-12-28 96" flexible dual limb | patient elbow with sampling port parallel wye | in-line mini HMEF with sample port large adult mask | M
30889483608962 - Anesthesia Circuit Kit 2023-12-28 120" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 3L la
30889483608979 - Anesthesia Circuit Kit 2023-12-28 60" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 3L late
30889483608986 - Anesthesia Circuit Kit 2023-12-28 60" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, large adult mask, M/M GSL 10' X .050ID X .108OD, 1
30889483608993 - Anesthesia Circuit Kit 2023-12-28 72" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 2L late
30889483609006 - Anesthesia Circuit Kit 2023-12-28 120" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, large adult mask, M/M GSL 10' X .050ID X .108OD, 1

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.