N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00613994653345
• Version / Model: 44405
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Labeler DUNS: 089055867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c6e2a707-e82f-42fb-bbca-41ba0872c89c

Device Description

CATHETER 44405 LUMBAR CLOSED TIP

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: 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61525	Lumboperitoneal shunt spinal catheter	A sterile implantable tube that is a component of a lumboperitoneal (LP) shunt intended to channel cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine in the management of elevated intracranial pressure due to increased CSF (hydrocephalus). It consists of a flexible tube fully implanted in the lumbar spine region and connected to a LP shunt valve. It is made of plastic materials and 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	00613994653345	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123524	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	0.7	Millimeter