DEVICE: ECG Cables and Leadsets (20884838006793)

Device Identifier (DI) Information

ECG Cables and Leadsets
Preattached leadwire electrode, Square
In Commercial Distribution
989803100551
Philips Medical Systems Hsg
20884838006793
GS1

100
790605856 *Terms of Use
Preattached leadwire electrode, Square Radiolucent carbon AAMI color 45cm/18" leadwires with 1.5mm/.060" safety socket square 22cm x 22cm cloth backing with Ag/Cl sensor, 3/pouch, 300/case.
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35035 Electrocardiographic electrode, single-use
A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). 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., 10) connected to appropriate leads and cables. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DRY MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
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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

[?]
Storage and Handling
Storage Environment Temperature: between -25 and 45 Degrees Celsius
Storage Environment Humidity: between 0 and 100 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

3a8ca3d0-ef28-4cbe-8fe9-8b7104ba83cd
June 04, 2024
10
January 03, 2017
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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
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

[?]
Unit of Use DI Number: 10884838006796 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(999)999-9999
xx@xx.xx
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