AirLife™ - Vests for Biliblanket® Phototherapy System, - Vyaire Medical Oy

Duns Number:368457563

Device Description: Vests for Biliblanket® Phototherapy System, Disposable

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More Product Details

Catalog Number

6600-0461-200

Brand Name

AirLife™

Version/Model Number

6600-0461-200

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

KME

Product Code Name

Bedding, Disposable, Medical

Device Record Status

Public Device Record Key

3d758a27-1879-45ea-a610-931d877c8a43

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 29, 2021

Additional Identifiers

Package DI Number

20190752111780

Quantity per Package

10

Contains DI Package

70190752111785

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