DEVICE: MEDALink (G096MMRBPADT100)

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Device Record History
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Device Identifier (DI) Information
MEDALink
M-MR-BP-ADT-10
In Commercial Distribution
M-MR-BP-ADT-10
Rising Eagle Medical LLC
G096MMRBPADT100
HIBCC

1
080145608 *Terms of Use
Reusable Mindray Compatible NIBP tubing, Adult/Pediatric/Infant/Neonate, 10 ft (1EA)
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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?
66921 Blood pressure/neuromuscular transmission monitoring cuff extension tubing/cable
A length of pneumatic tubing with an integrated electrical cable intended to be connected to the existing tubing/cable of a blood pressure/neuromuscular transmission monitoring cuff (not included) to increase its length, during combined intraoperative noninvasive blood pressure (NIBP) and neuromuscular transmission (NMT) monitoring. 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
No Device Sizes
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Device Record Status
81017b0b-cc58-4de7-a6f9-da36e18d82b4
September 27, 2024
1
September 19, 2024
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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

[?]
No Customer Contact currently defined
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