Catalog Number

5562.613N

Brand Name

VYGON

Version/Model Number

5562.613N

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

53453aee-785b-4377-af46-a77bfad0622d

Public Version Date

September 24, 2018

Public Version Number

4

DI Record Publish Date

September 06, 2016

Package DI Number

38498840009841

Quantity per Package

5

Contains DI Package

08498840009840

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-