DEVICE: SynchroMed® II (00643169530119)

Device Identifier (DI) Information

SynchroMed® II
8637-20
In Commercial Distribution

MEDTRONIC, INC.
00643169530119
GS1

1
796986144 *Terms of Use
PUMP 8637-20 SYNCHMED II 20ML DLC MOTOR
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
Yes
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?
46024 Implantable intrathecal infusion pump, programmable
A battery-powered programmable device designed to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant origin. This implantable infusion pump (IIP) delivers drug doses from its implanted refillable reservoir which is controlled by drug concentration and/or by radio-frequency (RF) signals from an external programming device. The drug reservoir, usually implanted under the skin of the lower abdomen, is typically connected to a catheter placed into the spinal fluid space.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LKK PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P860004 261
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: No Magnets
Storage Environment Temperature: between 41 and 110 Degrees Fahrenheit
Storage Environment Temperature: between 5 and 43 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 20.0 Milliliter
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Device Record Status

830a2a07-444c-496f-9c95-12befde36931
April 03, 2024
5
July 17, 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

[?]
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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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