Catalog Number

80004003

Brand Name

HydroMID Full Kit

Version/Model Number

80004003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K203069

Product Code

FOZ

Product Code Name

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Public Device Record Key

da572bd9-1d90-4ec6-9d49-123433d8eebf

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

October 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-