Catalog Number

8888422113

Brand Name

Argyle

Version/Model Number

8888422113

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"

Yes

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

K890288,K890288

Product Code

FJS

Product Code Name

Catheter, Peritoneal, Long-Term Indwelling

Public Device Record Key

f23de6be-34cc-475f-9575-d79b695c1a5c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 15, 2016

Package DI Number

20884521084480

Quantity per Package

5

Contains DI Package

10884521084483

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK