DEVICE: SynchroMed® II (00643169530119)
Device Identifier (DI) Information
SynchroMed® II
8637-20
In Commercial Distribution
MEDTRONIC, INC.
8637-20
In Commercial Distribution
MEDTRONIC, INC.
PUMP 8637-20 SYNCHMED II 20ML DLC MOTOR
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 | 261 |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 20.0 Milliliter |
Device Record Status
830a2a07-444c-496f-9c95-12befde36931
April 03, 2024
5
July 17, 2017
April 03, 2024
5
July 17, 2017
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