Catalog Number

DMBCA

Brand Name

N/AN/A

Version/Model Number

DMBCA

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

-

Product Code

FJS

Product Code Name

Catheter, peritoneal, long-term indwelling

Public Device Record Key

da80f3eb-7d77-4b50-bc49-7bf6333ff770

Public Version Date

September 09, 2019

Public Version Number

1

DI Record Publish Date

August 30, 2019

Package DI Number

50884908145217

Quantity per Package

20

Contains DI Package

00884908145212

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box