DEVICE: Neuroline 700Neurology Surface Electrodes (05707480028658)

Device Identifier (DI) Information

Neuroline 700Neurology Surface Electrodes
70010-K/C/12
In Commercial Distribution
70010-K/C/12
Ambu A/S
05707480028658
GS1

12
305682023 *Terms of Use
Solid Gel Electrodes K Connector Lead Wire Length: 100 cm (40")
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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
Analytical non-scalp cutaneous electrode A non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
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FDA Product Code

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Product Code Product Code Name
GXY ELECTRODE, CUTANEOUS
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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 10 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

7fbf4bf9-692f-48f3-bcaa-43af105b8a0a
March 29, 2018
2
September 21, 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
05707480028641 10 05707480028658 In Commercial Distribution
05707480000456 8 05707480028641 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

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Unit of Use DI Number: 05707480028665 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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