Ambu WhiteSensor 5050 - White Sensor 5050-00-A/50 ECG electrode Wet gel, - Ambu A/S

Duns Number:305682023

Device Description: White Sensor 5050-00-A/50 ECG electrode Wet gel, foam backing and offset connector Pouch 5 White Sensor 5050-00-A/50 ECG electrode Wet gel, foam backing and offset connector Pouch 50 pcs. /box 1000 pcs / carton 6000 pcs

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More Product Details

Catalog Number

5050-00-S/50

Brand Name

Ambu WhiteSensor 5050

Version/Model Number

5050-00-S/50

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 10, 2020

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

66541dbb-8dce-4ce5-b988-05e56183c808

Public Version Date

September 10, 2020

Public Version Number

2

DI Record Publish Date

August 05, 2019

Additional Identifiers

Package DI Number

05707480136827

Quantity per Package

6

Contains DI Package

05707480136810

Package Discontinue Date

September 10, 2020

Package Status

Not in Commercial Distribution

Package Type

-

"AMBU A/S" 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. 309