MEDSTREAM

Basic Information

• Brand Name: MEDSTREAM
• Primary DI: 10886704071457
• Version / Model: 91-4285US
• Catalog Number: 914285US
• Company Name: Codman Neuro Sciences Sàrl
• Labeler DUNS: 481401680
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-20
• Public Version: 3
• Public Version Date: 2022-01-28
• Public Version Status: Update
• Public Device Record Key: 80f1e872-5a37-440f-ab10-c0481bb27079
• Distribution End Date: 2024-12-31

Device Description

Refill 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: 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
46024	Implantable intrathecal infusion pump, programmable	A battery-powered, programmable, sterile device designed to be implanted in a patient for the storing and subarachnoid (intrathecal) 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) delivers drug doses from its implanted reservoir which is controlled by drug concentration and/or by radio-frequency (RF) signals from an external programming device. The drug reservoir, usually implanted under the skin of the lower abdomen, is typically connected to a 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	20886704071454	GS1	Package	6	In Commercial Distribution	2024-12-31
Primary	10886704071457	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P890055	026
P890055	047

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if opened or damaged.