DEVICE: CODMAN (10886704043591)
Device Identifier (DI) Information
CODMAN
AP-03000H
Not in Commercial Distribution
AP03000H
CODMAN & SHURTLEFF, INC.
AP-03000H
Not in Commercial Distribution
AP03000H
CODMAN & SHURTLEFF, INC.
Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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 | 001 |
P890055 | 002 |
P890055 | 003 |
P890055 | 006 |
P890055 | 010 |
P890055 | 011 |
P890055 | 013 |
P890055 | 014 |
P890055 | 015 |
P890055 | 017 |
P890055 | 019 |
P890055 | 052 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Protect package from water |
Special Storage Condition, Specify: Do not drop |
Special Storage Condition, Specify: Do not use if opened or damaged. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
5c635479-4fc1-41b2-8381-88a27b0e9bfd
January 28, 2022
4
September 20, 2014
January 28, 2022
4
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 |
---|---|---|---|---|---|
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)255-2500
xx@xx.xx
xx@xx.xx