3100A HFOV - Flexible Patient Circuit, 3100A MR730 in - VYAIRE MEDICAL, INC.

Duns Number:080456871

Device Description: Flexible Patient Circuit, 3100A MR730 in Non-Heated Environment (Box of 4)

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More Product Details

Catalog Number

29028-002

Brand Name

3100A HFOV

Version/Model Number

29028-002

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

P890057

Product Code Details

Product Code

LSZ

Product Code Name

VENTILATOR, HIGH FREQUENCY

Device Record Status

Public Device Record Key

8d48f4ff-6f20-4bd5-b417-e774def83fed

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

May 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VYAIRE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 780
3 A medical device with high risk that requires premarket approval 65
U Unclassified 1