SURESTREAM

Basic Information

• Brand Name: SURESTREAM
• Primary DI: 10886704072560
• Version / Model: 70029US
• Catalog Number: 70029US
• 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: 2023-01-02
• Public Version Status: Update
• Public Device Record Key: b3f780cd-4ed3-4526-b00f-014e8467471e
• Distribution End Date: 2022-12-31

Device Description

Intraspinal Catheter Connector with Strain Relief Sleeve

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	10886704072560	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P890055	018
P890055	021
P890055	023
P890055	027
P890055	038

Storage Conditions

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