Natus®

Primary DI
00382830055826
Brand
Natus®
Company
NATUS MEDICAL INCORPORATED
Model
NT999304
Catalog number
NT999304
Device description
CSF Reservoir Kit (With Straight Catheter F8, 15 cm)
Published
2020-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKGPort & Catheter, Implanted, Subcutaneous, Intraventricular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKGPort & Catheter, Implanted, Subcutaneous, IntraventricularNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950315000CORDIS CSF RESERVOIRCordis Corp.1995-05-09LKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780034612PreviousGS10
00382830055826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178003461210381780034612
00382830055826003828300558263828300558260382830055826

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral infusion/drainage catheter, long-termA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-356-0007Madison.Helpdesk@Natus.com

Regulatory Flags#

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

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00382830000796Bio-logicOAE Foam Tip Adult203212, 294282017-03-31
00382830000819Bio-logicOAE Tree Tip203218, 294222017-03-31
00382830000826Bio-logicOAE Tree Tip Preemie2032192017-03-31
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000980863ReservoirMicro Therapeutics, Inc.LKG2025-08-03
00763000980856ReservoirMEDTRONIC POWERED SURGICAL SOLUTIONSLKG2025-07-31
00763000028268N/AMEDTRONIC PS MEDICAL, INC.LKG2020-04-20
00763000028275N/AMEDTRONIC PS MEDICAL, INC.LKG2020-04-19
00763000030612N/AMicro Therapeutics, Inc.LKG2020-04-19
00763000030636N/AMEDTRONIC POWERED SURGICAL SOLUTIONSLKG2020-04-19
00763000031107N/AMEDTRONIC POWERED SURGICAL SOLUTIONSLKG2020-04-19
00382830055772Natus®NATUS MEDICAL INCORPORATEDLKG2020-04-03
00382830056212Natus®NATUS MEDICAL INCORPORATEDLKG2020-04-03
00763000028237N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028244N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028251N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028503N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028510N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028527N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028534N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029197N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029203N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029685N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029869InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029876InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029883InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029890InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029906InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029913InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029920InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000030155N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000030285N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000030292N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20