DEVICE: SYNCHROMED®II (00763000422615)

Device Identifier (DI) Information

SYNCHROMED®II
8637-40
In Commercial Distribution

MEDTRONIC, INC.
00763000422615
GS1

1
796986144 *Terms of Use
PUMP 8637-40 SM II 40ML EMAN SYMBL GRC
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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 369
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Sterilization

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

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

de5db3dc-c9ae-4f86-9ac3-fc15819e60d4
April 19, 2021
1
April 11, 2021
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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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