Catalog Number

622284

Brand Name

ASEPT

Version/Model Number

622284

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

K093796

Product Code

FJS

Product Code Name

CATHETER, PERITONEAL, LONG-TERM INDWELLING

Public Device Record Key

030a9ca2-7f31-4bdb-b2e1-6f4bf0d30bbd

Public Version Date

April 07, 2020

Public Version Number

6

DI Record Publish Date

July 26, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-