DEVICE: CODMAN (10886704043614)

Device Identifier (DI) Information

CODMAN
AP-03000M
Not in Commercial Distribution
AP03000M
Cerenovus, Inc.
10886704043614
GS1
December 31, 2021
1
607846297 *Terms of Use
Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LKK PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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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
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Do not use if opened or damaged.
Special Storage Condition, Specify: Do not drop
Special Storage Condition, Specify: Protect package from water
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

989b3923-f2e4-42f2-803f-1c9b15fbbfed
September 15, 2023
5
September 20, 2014
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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
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Secondary DI

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

[?]
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

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
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