Smart Charger - Single Item Packaging

GUDID 07640168020521

Sequana Medical NV, Ghent, Zweigniederlassung Zürich

Abdominal fluid shunt system
Primary Device ID07640168020521
NIH Device Record Key18a57692-77af-478e-8545-284a363c38e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart Charger - Single Item Packaging
Version Model Number02475
Company DUNS480401893
Company NameSequana Medical NV, Ghent, Zweigniederlassung Zürich
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107640168020521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SDQAlfapump System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-18
Device Publish Date2025-08-08

Devices Manufactured by Sequana Medical NV, Ghent, Zweigniederlassung Zürich

07640168020507 - alfapump System2025-08-18 alfapump System (catalog number 01485) is composed of the following devices: 01473 - alfapump 01474 - Bladder Catheter 01478 - T
07640168020521 - Smart Charger - Single Item Packaging2025-08-18
07640168020521 - Smart Charger - Single Item Packaging2025-08-18
07640168020538 - Docking Station - Single Item Packaging2025-08-18
07640168020545 - Implant Accessories - Single Item Packaging2025-08-18
07640168020798 - Introducer Kit - Single Item Packaging2025-08-18
07640168020804 - Peritoneal Catheter SNCA-5262L - Single Item Packaging2025-08-18
07640168020828 - Tunneling Rod - Single Item Packaging2025-08-18
07640168020880 - alfapump - Single Item Packaging2025-08-18

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