Natus®

Basic Information

• Brand Name: Natus®
• Primary DI: 00382830055833
• Version / Model: NTCFRL
• Catalog Number: NTCFRL
• 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: 2
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 152a8574-77f9-4a4e-9dc0-efc853015bde

Device Description

Contour-Flex Valve Unit, Regular, Low Pressure At 20 ml/hr: 1.2 - 5.8 cm H2O

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
JXG	Shunt, Central Nervous System And Components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61123	Ventriculo-peritoneal/atrial shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to either the peritoneal cavity or the heart right atrium (i.e., dual-capability), where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It consists of: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal/atrial catheter that channels the CSF to the peritoneal cavity or right atrium; some types have a port/reservoir for hypodermic sampling/infusion. 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	00382830055833	GS1
Previous	10381780457558	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033698	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Low Pressure at 20ml/h: 1.2-5.8cmH2O