DEVICE: CODMAN (10886704043621)

Device Identifier (DI) Information

CODMAN
AP-03000UL
Not in Commercial Distribution
AP03000UL
Cerenovus, Inc.
10886704043621
GS1
December 31, 2021
1
607846297 *Terms of Use
Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
CLOSE

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. 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 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 refillable drug reservoir, usually implanted under the skin of the lower abdomen, and a connected catheter placed into the spinal fluid space.
Active true
CLOSE

FDA Product Code

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

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
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

1859570c-e181-41b1-8701-31d469dc8cb9
April 03, 2024
6
September 20, 2014
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

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