N/A - ECG Electrodes, 55mm Round, Foam, Hydrogel - Carefusion Finland 320 Oy

Duns Number:367919120

Device Description: ECG Electrodes, 55mm Round, Foam, Hydrogel

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More Product Details

Catalog Number

2009110-005

Brand Name

N/A

Version/Model Number

2009110-005

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"

Yes

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

-

Product Code Details

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Device Record Status

Public Device Record Key

20b8d1e3-ddeb-4547-a3b0-612d418d538c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

50885403253117

Quantity per Package

120

Contains DI Package

70885403253111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"CAREFUSION FINLAND 320 OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 363