Catalog Number

-

Brand Name

Edi Catheter ENFit 12Fr/125 cm, 5pcs

Version/Model Number

6883903

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K153688,K153688

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

8f0a76d4-aa4a-4c7b-98ca-b546c2764405

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 18, 2017

Package DI Number

17325710004668

Quantity per Package

5

Contains DI Package

07325710004661

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-