NA

Basic Information

• Brand Name: NA
• Primary DI: 10886704043737
• Version / Model: AP-04030
• Catalog Number: AP04030
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-20
• Public Version: 6
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: 9e5cb17a-baf4-46b8-a27d-843d86e46024
• Distribution End Date: 2023-07-28

Device Description

Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• 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
Package	20886704043734	GS1	Case	15	Not in Commercial Distribution	2023-07-28
Primary	10886704043737	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P890055	021

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if opened or damaged.