Catalog Number

611809

Brand Name

Z-MED™

Version/Model Number

611809

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

K122012,K991977

Product Code

LIT

Product Code Name

Catheter, angioplasty, peripheral, transluminal

Public Device Record Key

98b10992-c98c-440a-bf46-6f6cd2aec1aa

Public Version Date

December 14, 2021

Public Version Number

4

DI Record Publish Date

August 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-