DEVICE: Ambu Neuroline Concentric Cable,Lenght of leadwire: 100 cm (39") (05707480000029)

Device Identifier (DI) Information

Ambu Neuroline Concentric Cable,Lenght of leadwire: 100 cm (39")
1741
In Commercial Distribution
1741
Ambu A/S
05707480000029
GS1

1
305682023 *Terms of Use
Lead Wire Length: 100 cm (40") Connector: DIN (60130-9)
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Analytical non-scalp cutaneous lead An insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
IKD CABLE, ELECTRODE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 100 Centimeter
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Device Record Status

2fcd9298-d0fd-4662-9a48-d3c2361386f6
March 29, 2018
2
September 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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+14107686464
Purchase_orders@ambuUSA.com
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