Catalog Number

VYPL5T1001

Brand Name

VYGON

Version/Model Number

VYPL5T1001

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

K172899,K172899

Product Code

LJS

Product Code Name

Catheter, intravascular, therapeutic, long-term greater than 30 days

Public Device Record Key

76beceec-8dc2-405a-a314-1d8fde655a1a

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 26, 2019

Package DI Number

38498840012063

Quantity per Package

5

Contains DI Package

08498840012062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-