Catalog Number

5570.13

Brand Name

VYGON

Version/Model Number

5570.13

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K013884,K013884,K013884

Product Code

BYE

Product Code Name

Attachment, breathing, positive end expiratory pressure

Public Device Record Key

00198bf7-66a1-4d88-83d8-db19829cf114

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

53660812032846

Quantity per Package

12

Contains DI Package

33660812032842

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-