FDA.reportPublic FDA data

Cleveland Multiport Ventricular Catheter Set

Primary DI
00860002624914
Brand
Cleveland Multiport Ventricular Catheter Set
Company
PARKER-HANNIFIN CORPORATION
Model
A
Published
2020-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HCACatheter, Ventricular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCACatheter, VentricularNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161731000Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp.2017-03-27HCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002624921PackageGS11In Commercial Distribution
00860002624914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002624921008600026249218600026249210860002624921
00860002624914008600026249148600026249140860002624914

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
Ethylene Oxide

Regulatory Flags#

DUNS number
005097598
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816711024972MATRX SCAV(WO/HOOD)WO/SHUTOFF91515197915151972026-02-23
00816711020097ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEM40151601 KOR2025-09-24
00816711020424NITRONOX SCAVENGERNOX-53002025-09-24
00816711024958PORTER,MED BR CIR,6FT,20PCKDMC-12-6DMC-12-62025-09-17
00816711024965PORTER,MED BR CIR,10FT,20PCKDMC-12-10DMC-12-102025-09-17
00816711024941HOSE N2O DISS/DISS 8 FT850885082025-02-27
00816711024224SCAVENGER, EAVS, MIDASEAVS-5000EAVS-50002025-02-21
00816711024927DEMAND VALVE, POS PR., DISS1506-1D1506-1D2025-02-21
00816711024934HA,O2,INTL (DISSF X DISSF)2FT92305297-2 92305297-2 2025-02-21
00816711024439DIGITAL MDM ASSY-120V(STAND MT40151602 915251152024-04-05
00816711023821Digital MDM, 30% Std ISO40151602 915251762023-09-05
00816711023838DIGITAL MDM 30% GERMANY91525178915251782023-09-05
00816711023845INTL DMDM (STAND)-SPAIN91525179915251792023-09-05
00816711023852INTL DMDM 40% STAND-SWEDEN91525180915251802023-09-05
00816711023869INTL DMDM (STAND)-ISRAEL91525182915251822023-09-05
00816711023876INTL DMDM,STANDARD-AUSTRALIA91525184915251842023-09-05
00816711023883INTL DMDM (STAND)-DUTCH91525185915251852023-09-05
00816711023890INTL DMDM (STAND)-CANADA91525186915251862023-09-05
00816711023906INTL DMDM,CABINET MOUNT91525187915251872023-09-05
00816711023913INTL DMDM 30%(STAND)-ITALY91525262915252622023-09-05

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