DEVICE: SYNCHROMED® II (00763000634094)
Device Identifier (DI) Information
SYNCHROMED® II
8637-20
In Commercial Distribution
MEDTRONIC, INC.
8637-20
In Commercial Distribution
MEDTRONIC, INC.
PUMP 8637-20 SM II 20ML EMAN SYMBL
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LKK | Pump, infusion, implanted, programmable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P860004 | 378 |
P860004 | 380 |
P860004 | 387 |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Reservoir Volume 20 ML |
Device Record Status
6b71927c-5ca1-47b4-8d5b-c3f26b45a681
April 03, 2024
3
August 11, 2022
April 03, 2024
3
August 11, 2022
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com