Vyaire - Description: 9% He, 35% O2, Bal. N2;Cylinder: ED; - AIRGAS USA LLC

Duns Number:831996595

Device Description: Description: 9% He, 35% O2, Bal. N2;Cylinder: ED; Valve: CGA 973;For use with Vyaire's Pul Description: 9% He, 35% O2, Bal. N2;Cylinder: ED; Valve: CGA 973;For use with Vyaire's Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.; CE Marked;Vyaire Part #: 001-899150

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More Product Details

Catalog Number

Z03NI56JED0000

Brand Name

Vyaire

Version/Model Number

Pulmonary Function Cal Gas

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

BXK

Product Code Name

Gas, Calibration (Specified Concentration)

Device Record Status

Public Device Record Key

ed5bf90f-9b81-4640-af81-689ee80bbd2e

Public Version Date

January 08, 2020

Public Version Number

1

DI Record Publish Date

December 31, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AIRGAS USA LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 281
2 A medical device with a moderate to high risk that requires special controls. 2