Catalog Number

901063-17

Brand Name

Enhanced Peripheral

Version/Model Number

Enhanced Peripheral, 195-12G

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

5a49d80c-fe0e-4730-908d-d63a26288a8b

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

May 15, 2020

Package DI Number

10816349012126

Quantity per Package

5

Contains DI Package

00816349012129

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton