Catalog Number

040-0522-01

Brand Name

Spacelabs Healthcare

Version/Model Number

96280

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2019

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

K141156

Product Code

DSI

Product Code Name

DETECTOR AND ALARM, ARRHYTHMIA

Public Device Record Key

5c894b1a-d579-4a1e-9b8a-3b79f7535603

Public Version Date

July 31, 2019

Public Version Number

11

DI Record Publish Date

December 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-