DEVICE: NA (10886704043720)
Device Identifier (DI) Information
NA
AP-04013-5
In Commercial Distribution
AP040135
Medos International Sàrl
AP-04013-5
In Commercial Distribution
AP040135
Medos International Sàrl
Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 1 3/8inch (3.5 cm)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
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, nonprogrammable | A battery-powered, nonprogrammable, sterile device designed to be implanted in a patient for the storing and subarachnoid 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) may enable delivery of a bolus of medication, typically patient-controlled with mechanical restrictions that limit the refill rate of the device, or it may provide a constant flow of medication at a factory-set rate. The device typically consists of a drug reservoir, usually implanted under the skin of the lower abdomen, and a connected catheter placed into the spinal fluid space. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P890055 | 010 |
P890055 | 021 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 25 Degrees Celsius |
Handling Environment Temperature: between 15 and 25 Degrees Celsius |
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit |
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit |
Special Storage Condition, Specify: Do not use if opened or damaged. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
bed3ecf8-a331-4eba-ad9a-003009a3e4c8
January 28, 2022
5
September 20, 2014
January 28, 2022
5
September 20, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20886704043727 | 5 | 10886704043720 | 2023-07-28 | In Commercial Distribution | Case |
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)255-2500
xx@xx.xx
xx@xx.xx