LUCAS™ Chest Compression System - LUCAS 2, 2.2, IN SHIPPING BOX,EN - Jolife AB

Duns Number:632662933

Device Description: LUCAS 2, 2.2, IN SHIPPING BOX,EN

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More Product Details

Catalog Number

99576-000024

Brand Name

LUCAS™ Chest Compression System

Version/Model Number

99576

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DRM

Product Code Name

COMPRESSOR, CARDIAC, EXTERNAL

Device Record Status

Public Device Record Key

c6eebe8f-4c78-47b6-baba-5f0ee3c3cc6b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 04, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JOLIFE AB" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6