Vital Signs™ - Co-axial Breathing Circuit, Adult, Disposable, - Vyaire Medical Oy

Duns Number:368457563

Device Description: Co-axial Breathing Circuit, Adult, Disposable, 1.5 m/60 in With Gas Sampling Elbow, HMEF 7 Co-axial Breathing Circuit, Adult, Disposable, 1.5 m/60 in With Gas Sampling Elbow, HMEF 750/S, Manual Bag, 3 L and Size 6 Face Mask With Hook Ring

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More Product Details

Catalog Number

-

Brand Name

Vital Signs™

Version/Model Number

M1145542

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"

Yes

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

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Device Record Status

Public Device Record Key

a0d0ca71-bfe3-4c45-a8df-87d1eec0b1c5

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

September 01, 2019

Additional Identifiers

Package DI Number

20190752109244

Quantity per Package

20

Contains DI Package

10190752109247

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