DEVICE: CODMAN (10886704043829)
Device Identifier (DI) Information
CODMAN
AP-09150
Not in Commercial Distribution
AP09150
Cerenovus, Inc.
AP-09150
Not in Commercial Distribution
AP09150
Cerenovus, Inc.
3000 Series High Temperature Drape for use with CODMAN O.R. Heater AP-09100
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
34071 | 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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P890055 | 012 |
P890055 | 017 |
P890055 | 021 |
P890055 | 023 |
P890055 | 027 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between -20 and 40 Degrees Celsius |
Storage Environment Temperature: between -20 and 40 Degrees Celsius |
Special Storage Condition, Specify: Do not use if opened or damaged. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1ef14a30-64d0-470c-b7a6-6541d7f7e785
September 15, 2023
5
September 20, 2014
September 15, 2023
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 |
---|---|---|---|---|---|
20886704043826 | 5 | 10886704043829 | 2021-12-31 | Not 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