NA

Basic Information

• Brand Name: NA
• Primary DI: 10886704043751
• Version / Model: AP-07003
• Catalog Number: AP07003
• 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: 5
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: 9b678d5f-3fe9-4cf4-be5d-5d7d2f94a63d
• Distribution End Date: 2023-07-28

Device Description

For use with CODMAN 3000 Series Catheter Connector Length 0.45 inch (11mm) I.D. 0.029 inch (0.7mm) x O.D. 0.050 inch (1.3mm) Connects CODMAN 3000 Pump Catheter I.D. 0.025 inch (0.6mm) x O.D. 0.090 inch (2.3mm) To Intraspinal Catheter

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: Yes
• 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
61493	Spinal port/catheter	A sterile implantable device intended to provide access to the subarachnoid (intrathecal) space of the spinal column for infusion (e.g., chemotherapeutic agents, pain relieving drugs) and/or drainage [e.g., cerebrospinal fluid (CSF)]. It consists of a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle, attached to a distal catheter which passes into the target site. It is made of metal [e.g., titanium (Ti)] and synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886704043751	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P890055	016
P890055	017
P890055	020
P890055	021
P890055	023
P890055	027
P890055	038

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit