Natus®

Basic Information

• Brand Name: Natus®
• Primary DI: 00382830055826
• Version / Model: NT999304
• Catalog Number: NT999304
• Company Name: NATUS MEDICAL INCORPORATED
• Labeler DUNS: 081325959
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-03
• Public Version: 1
• Public Version Date: 2020-04-13
• Public Version Status: New
• Public Device Record Key: 75a0c6f9-844a-44b0-bb4e-41cbb5f5a08d

Device Description

CSF Reservoir Kit (With Straight Catheter F8, 15 cm)

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LKG	Port & Catheter, Implanted, Subcutaneous, Intraventricular	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61376	Intracerebral infusion/drainage catheter, long-term	A sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382830055826	GS1
Previous	10381780034612	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K950315	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Reservoir 0.6ml Internal Volume, Straight Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.