DEVICE: Ambu Neuroline Monopolar CableLength of leadwire: 76 cm (30") (05707480000074)

Device Identifier (DI) Information

Ambu Neuroline Monopolar CableLength of leadwire: 76 cm (30")
1744
In Commercial Distribution
1744
Ambu A/S
05707480000074
GS1

1
305682023 *Terms of Use
Lead Wire Length: 76 cm (30") Connector: 1.5 mm (DIN 42 802)
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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: 76 Centimeter
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Device Record Status

80f1e022-b204-43bc-8abf-f830c8a88b5b
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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
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