Catalog Number

-

Brand Name

Premier

Version/Model Number

050-30035

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

K822550,K822550

Product Code

FKX

Product Code Name

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Public Device Record Key

3fdb5177-2d54-462b-a3e3-768649886219

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 02, 2015

Package DI Number

10840861100689

Quantity per Package

50

Contains DI Package

00840861100682

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-