CODMAN

Basic Information

• Brand Name: CODMAN
• Primary DI: 10886704043591
• Version / Model: AP-03000H
• Catalog Number: AP03000H
• Company Name: Cerenovus, Inc.
• Labeler DUNS: 607846297
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-20
• Public Version: 5
• Public Version Date: 2023-09-15
• Public Version Status: Update
• Public Device Record Key: 5c635479-4fc1-41b2-8381-88a27b0e9bfd
• Distribution End Date: 2021-12-31

Device Description

Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKK	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886704043591	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect package from water
• Type: Special Storage Condition, Specify
• Special Conditions: Do not drop
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if opened or damaged.