Catalog Number

D138402

Brand Name

nGEN Generator

Version/Model Number

D138402

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

-

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

P990071,P010068,P030031,P040036,P950005,P990025

Product Code

DRF

Product Code Name

CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Public Device Record Key

7bf94063-b51e-42ac-80ea-c024d889d3e1

Public Version Date

August 26, 2022

Public Version Number

1

DI Record Publish Date

August 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-