FDA.reportPublic FDA data

Clinical Specialist Notebook Kit IV

Primary DI
07640168021191
Brand
Clinical Specialist Notebook Kit IV
Company
Sequana Medical NV, Ghent, Zweigniederlassung Zürich
Model
02400
Published
2025-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SDQAlfapump System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDQAlfapump SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230044001
P230044002
P230044003
P230044004
P230044005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230044001alfapump SystemSequana Medical NV2024-12-20SDQ
P230044002alfapump SystemSequana Medical NV2024-12-20SDQ
P230044003alfapump SystemSequana Medical NV2024-12-20SDQ
P230044004alfapump SystemSequana Medical NV2024-12-20SDQ
P230044005alfapump SystemSequana Medical NV2024-12-20SDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640168021191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640168021191076401680211917640168021191

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal fluid shunt system programming kitA collection of devices intended to be used by a clinician to noninvasively adjust the operating parameters of an implanted abdominal fluid shunt pump. It consists of dedicated programming software (e.g., for installation on an off-the-shelf computer), mains power cable, and a USB cable for connection to implant-communicating devices (e.g., charger which wirelessly communicates with the implant). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480401893
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640168020507alfapump System014852025-08-08
07640168020521Smart Charger - Single Item Packaging024752025-08-08
07640168020538Docking Station - Single Item Packaging024762025-08-08
07640168020545Implant Accessories - Single Item Packaging020242025-08-08
07640168020798Introducer Kit - Single Item Packaging021562025-08-08
07640168020804Peritoneal Catheter SNCA-5262L - Single Item Packaging021592025-08-08
07640168020828Tunneling Rod - Single Item Packaging021672025-08-08
07640168020880alfapump - Single Item Packaging024732025-08-08
07640168020897Bladder Catheter - Single Item Packaging024742025-08-08
07640168021160alfapump Programming Kit IV024022025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640168020507alfapump SystemSequana Medical NV, Ghent, Zweigniederlassung ZürichSDQ2025-08-08
07640168020521Smart Charger - Single Item PackagingSequana Medical NV, Ghent, Zweigniederlassung ZürichSDQ2025-08-08
07640168020538Docking Station - Single Item PackagingSequana Medical NV, Ghent, Zweigniederlassung ZürichSDQ2025-08-08
07640168020545Implant Accessories - Single Item PackagingSequana Medical NV, Ghent, Zweigniederlassung ZürichSDQ2025-08-08
07640168020798Introducer Kit - Single Item PackagingSequana Medical NV, Ghent, Zweigniederlassung ZürichSDQ2025-08-08
07640168020804Peritoneal Catheter SNCA-5262L - Single Item PackagingSequana Medical NV, Ghent, Zweigniederlassung ZürichSDQ2025-08-08
07640168020828Tunneling Rod - Single Item PackagingSequana Medical NV, Ghent, Zweigniederlassung ZürichSDQ2025-08-08
07640168020880alfapump - Single Item PackagingSequana Medical NV, Ghent, Zweigniederlassung ZürichSDQ2025-08-08
07640168020897Bladder Catheter - Single Item PackagingSequana Medical NV, Ghent, Zweigniederlassung ZürichSDQ2025-08-08
07640168021160alfapump Programming Kit IVSequana Medical NV, Ghent, Zweigniederlassung ZürichSDQ2025-08-08