Implant Accessories - Single Item Packaging

Primary DI
07640168020545
Brand
Implant Accessories - Single Item Packaging
Company
Sequana Medical NV, Ghent, Zweigniederlassung Zürich
Model
02024
Published
2025-08-08
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
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
07640168020545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640168020545076401680205457640168020545

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal fluid shunt systemAn assembly of implantable devices designed to actively drain ascitic fluid (ascites) from the abdominal cavity into the bladder for urinary voiding. It typically consists of a battery-powered, programmable pump implanted beneath the skin of the abdomen in a surgically-created pocket, and fluid draining catheters [one placed in the cavity (e.g., peritoneal) for fluid collection, and another that connects the pump to the urinary bladder]. The pump is typically charged and programmed transcutaneously using a noninvasive hand-held charger/programmer; some pumps are able to wirelessly transmit performance data to an external device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480401893
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
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
07640168021191Clinical Specialist Notebook Kit IV024002025-08-08

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
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
07640168021191Clinical Specialist Notebook Kit IVSequana Medical NV, Ghent, Zweigniederlassung ZürichSDQ2025-08-08