DEVICE: Ambu WhiteSensor WSECG Electrodes (05707480108428)

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Device Identifier (DI) Information

Ambu WhiteSensor WSECG Electrodes
WS-00-S/30
WS-00-S/30
Ambu A/S
05707480108428
GS1
30
Ambu WhiteSensor, WS - 30/pack, not clarified yet
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electrocardiographic electrode, single-use A non-sterile electrical conductor designed to transmit cardiac bioelectric signals (typically from the thoracic surface) to devices that record and/or process the signals (e.g., electrocardiographs, vectorcardiographs, electrocardiographic monitors). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DRX Electrode, electrocardiograph
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 26, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05707480108442 12 05707480108435 In Commercial Distribution
05707480108435 20 05707480108428 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 05707480108411 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
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