Catalog Number

80516.30D

Brand Name

VYGON

Version/Model Number

80516.30D

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

K813373,K813373,K813373

Product Code

BTR

Product Code Name

Tube, tracheal (w/wo connector)

Public Device Record Key

650071b6-9a9e-423b-9b59-3fd3929dfd39

Public Version Date

November 23, 2020

Public Version Number

5

DI Record Publish Date

February 28, 2018

Package DI Number

33660812023857

Quantity per Package

25

Contains DI Package

03660812023856

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box