Catalog Number

5562.513N

Brand Name

VYGON

Version/Model Number

5562.513N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K013884,K013884

Product Code

BYE

Product Code Name

Attachment, breathing, positive end expiratory pressure

Public Device Record Key

156367ae-d21a-4899-a526-c27119a8bf40

Public Version Date

March 20, 2020

Public Version Number

1

DI Record Publish Date

March 12, 2020

Package DI Number

38498840012131

Quantity per Package

5

Contains DI Package

08498840012130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-