Catalog Number

AI-07155-KS

Brand Name

ARROW

Version/Model Number

IPN000096

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

K945229,K945229

Product Code

DRF

Product Code Name

CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Public Device Record Key

94140999-3373-44ed-a15d-5fe3ece7405a

Public Version Date

October 24, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

30801902004537

Quantity per Package

5

Contains DI Package

00801902004536

Package Discontinue Date

September 24, 2018

Package Status

Not in Commercial Distribution

Package Type

Case