DEVICE: CODMAN (10886704044109)

Device Identifier (DI) Information

CODMAN
IP-40820
In Commercial Distribution
IP40820
CODMAN & SHURTLEFF, INC.
10886704044109
GS1

1
607846297 *Terms of Use
Models 400 and 550 Implantable Infusion Pump Refill Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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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.
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FDA Product Code

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Product Code Product Code Name
LKK PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P800036 024
P800036 029
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Do not use if opened or damaged.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

8cc6e833-7edb-4208-845d-47190f9d94af
January 14, 2020
5
September 20, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(800)255-2500
xx@xx.xx
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