DEVICE: SYNCHROMED® II (00763000634094)

Device Identifier (DI) Information

SYNCHROMED® II
8637-20
In Commercial Distribution

MEDTRONIC, INC.
00763000634094
GS1

1
796986144 *Terms of Use
PUMP 8637-20 SM II 20ML EMAN SYMBL
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
Yes
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Implantable intrathecal infusion pump, programmable A battery-powered, programmable, sterile 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 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.
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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 378
P860004 380
P860004 387
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Handling Environment Temperature: between 5 and 55 Degrees Celsius
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between 41 and 131 Degrees Fahrenheit
Special Storage Condition, Specify: Do not freeze
Special Storage Condition, Specify: Keep away from magnets
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Reservoir Volume 20 ML
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Device Record Status

6b71927c-5ca1-47b4-8d5b-c3f26b45a681
September 30, 2022
2
August 11, 2022
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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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