N/A - T-Piece Neonatal Patient Circuit Kit, Disposable - Vyaire Medical Oy

Duns Number:368457563

Device Description: T-Piece Neonatal Patient Circuit Kit, Disposable

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

M1091335VS

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

K093913,K093913

Product Code Details

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Device Record Status

Public Device Record Key

fc4d0701-34e7-4e16-b9a7-734f0951b62e

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

April 15, 2019

Additional Identifiers

Package DI Number

20190752135687

Quantity per Package

10

Contains DI Package

10190752135680

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