Catalog Number

25-0025

Brand Name

Spacelabs Healthcare

Version/Model Number

CCOLLECT; CDIRECT; PXCABLES; CD12USB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 20, 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

-

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

ca5ceaca-15b7-44eb-bee2-a943b9198290

Public Version Date

June 20, 2019

Public Version Number

3

DI Record Publish Date

February 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-