MEDSTREAM

Basic Information

• Brand Name: MEDSTREAM
• Primary DI: 10886704064930
• Version / Model: 91-4201US
• Catalog Number: 91-4201US
• 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: 4
• Public Version Date: 2023-09-15
• Public Version Status: Update
• Public Device Record Key: 9c7f2604-17e8-4a13-9fd2-4c3e8e4ca7ec
• Distribution End Date: 2017-09-28

Device Description

Programmable Infusion System Includes: MEDSTREAM Pump;Pump Catheter;Operating Room Prep Kit;Pump Documentation and Information Manual

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: MR Conditional
• 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
35687	General-purpose implantable infusion pump, programmable	A battery-powered, sterile device designed to be implanted in a patient for the long-term or intermittent infusion of narcotics, short-acting anaesthetic agents, antineoplastic drugs, and other agents. 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. A catheter connected to the reservoir is inserted into the epidural or subarachnoid (intrathecal) space of the spinal canal or into a blood vessel.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886704064930	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P890055	026

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity