NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER

Primary DI
00382830050548
Brand
NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER
Company
NATUS MEDICAL INCORPORATED
Model
NT821730C
Device description
NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER
Published
2024-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JXGShunt, Central Nervous System And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162437000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162437000Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc.2016-10-28JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830050548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830050548003828300505483828300505480382830050548

GMDN Terms#

Term, Definition table
TermDefinition
Ventricular cerebrospinal fluid drainage catheterization kitA collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081325959
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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