Catalog Number

5500100

Brand Name

Soft-Cell PC-2 Dialysis Catheter Kit 12.5 F x 17 cm

Version/Model Number

5500100

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

-

Product Code

LFJ

Product Code Name

CATHETER, SUBCLAVIAN

Public Device Record Key

edf1e833-35a5-44c3-86d5-7e20d07aa655

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

May 29, 2017

Package DI Number

10801741012362

Quantity per Package

5

Contains DI Package

00801741012365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA