DEVICE: Medstorm Defibrillator Pad (00863095000108)

Device Identifier (DI) Information

Medstorm Defibrillator Pad
T100-CS
In Commercial Distribution
16382
BOUND TREE MEDICAL, LLC
00863095000108
GS1

1
070556204 *Terms of Use
Medstorm Multi Function Defibrillator Pas, Cardiac Science, Adult, Translucent
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
External defibrillator electrode pad A conductive medium designed to be used between the metal contact surface of an external defibrillator electrode, of the paddle-type, and the patient's skin. A defibrillator electrode pad is available in two basic designs: 1) a thickened conductive gel or polymer layer reinforced by a non-woven material; or 2) a conductive adhesive pad with a metal contact on its outer surface. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MKJ Automated External Defibrillators (Non-Wearable)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131494 000
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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

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Size Type Text
No Device Sizes
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Device Record Status

c40ada15-4f50-47d1-9ea6-f1ac59e17bf0
July 06, 2018
3
November 07, 2014
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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

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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
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
614-760-5000
adam.reuther@sarnova.com
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