DEVICE: Multi-Link™ (10889483573662)

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Device Record History
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Device Identifier (DI) Information
Multi-Link™
1554AAO
In Commercial Distribution
1554AAO
AirLife Finland Oy
10889483573662
GS1

1
368457563 *Terms of Use
10190752182158
Multi-Link™ Maternal ECG Cable and 3-Leadwire Set for Corometrics™, AHA, Round Connector, 2.4 m/8 ft
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Device Characteristics
MR Unsafe
No
Yes
No
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?
35562 Electrocardiographic lead set, reusable
A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DSA Cable, Transducer And Electrode, Patient, (Including Connector)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K980582 000
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 -22 and 140 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
c4cba70a-8a05-4759-b645-013cb90efd08
April 03, 2025
1
March 26, 2025
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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

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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
(800)433-2797
info@sun-med.com
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