Vios - Vios Nebulizer System, LC Sprint, custom label - PARI RESPIRATORY EQUIPMENT, INC.

Duns Number:804736098

Device Description: Vios Nebulizer System, LC Sprint, custom label

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More Product Details

Catalog Number

-

Brand Name

Vios

Version/Model Number

310F35-PC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092918,K092918

Product Code Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

eed1c854-1f66-4603-8a2b-82b301515f4a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 27, 2016

Additional Identifiers

Package DI Number

00744229311102

Quantity per Package

6

Contains DI Package

00744229310631

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"PARI RESPIRATORY EQUIPMENT, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 111