Vios Pro

GUDID 00744229100362

Tubing, replacement, Vios Pro

PARI RESPIRATORY EQUIPMENT, INC.

Nebulizing system delivery set, reusable
Primary Device ID00744229100362
NIH Device Record Key16186712-f6ae-44ac-8571-5397ee49cbcd
Commercial Distribution StatusIn Commercial Distribution
Brand NameVios Pro
Version Model Number041F4594
Company DUNS804736098
Company NamePARI RESPIRATORY EQUIPMENT, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100744229100362 [Package]
Contains: 00744229410898
Package: carton [12 Units]
In Commercial Distribution
GS100744229410898 [Primary]

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 Date2017-03-30

On-Brand Devices [Vios Pro]

00744229100362Tubing, replacement, Vios Pro
00744229312529Vios Pro, LC Sprint, custom label
00744229312536Vios Pro with LC Plus
00744229312512Vios Pro with LC Sprint
00744229312505Vios Pro, LC Sprint, custom label

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