Catalog Number

630-030

Brand Name

AccuSensor

Version/Model Number

630-030

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091856,K091856

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

9aacae1d-1611-42d1-9e3e-a14266b1270d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Package DI Number

10851491007163

Quantity per Package

20

Contains DI Package

00851491007166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case