DEVICE: Kendall (10885380197987)

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Device Record History
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Device Identifier (DI) Information
Kendall
33202
In Commercial Distribution
33202
Cardinal Health 200, LLC
10885380197987
GS1

1
961027315 *Terms of Use
Kendall DL Multi OEM Single Patient Use System, 5 Lead ECG, SpO2, Temp, Dual Connect Cable & Leadset
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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?
31683 Electrocardiographic lead switching adaptor
A switching device to which electrocardiograph (ECG) limb and chest leads may be attached. It is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations (e.g., leads I, II and III). This device will typically be used when the devices to be connected are from different manufacturer's, enabling them to mate together. This is a reusable device.
Active false
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FDA Product Code

[?]
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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 12 Feet
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Device Record Status
252d10b5-68f2-47bc-a0ad-0bce96d926fe
June 12, 2025
1
June 04, 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
50885380197985 10 20885380197984 In Commercial Distribution CASE
20885380197984 5 10885380197987 In Commercial Distribution BOX
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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

[?]
No Customer Contact currently defined
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