Vital Signs™ - Single Use Nasal Sampling Line, Large Adult Size, - Vyaire Medical Oy

Duns Number:368457563

Device Description: Single Use Nasal Sampling Line, Large Adult Size, 2m/7ft

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More Product Details

Catalog Number

878035

Brand Name

Vital Signs™

Version/Model Number

878035

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

Yes

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

-

Product Code Details

Product Code

CCL

Product Code Name

Analyzer, Gas, Oxygen, Gaseous-Phase

Device Record Status

Public Device Record Key

4c157be8-46f1-4600-b440-13f2e1d80a77

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

December 03, 2020

Additional Identifiers

Package DI Number

70190752140877

Quantity per Package

10

Contains DI Package

10190752140875

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"VYAIRE MEDICAL OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 600