Catalog Number

H93863

Brand Name

REPEATER

Version/Model Number

H93863

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

K062909,K062909

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

f8b59358-a103-4d7f-9d83-a945256bcddc

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

50085412476693

Quantity per Package

10

Contains DI Package

00085412476698

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE