Catalog Number

-

Brand Name

Biowy PICC Catheter S Kit

Version/Model Number

PICC4SK-S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K192246,K192246,K192246

Product Code

LJS

Product Code Name

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Public Device Record Key

7f0cd9a9-0867-4e09-a4d8-c28c6aae3101

Public Version Date

June 01, 2021

Public Version Number

1

DI Record Publish Date

May 24, 2021

Package DI Number

00851739007194

Quantity per Package

5

Contains DI Package

00851739007156

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box