FDA.reportPublic FDA data

DAAVLIN

Primary DI
04250571300818
Brand
DAAVLIN
Company
HIDREX GmbH
Model
Aquex (DAAV1000)
Catalog number
DAAV16110
Device description
Daavlin Aquex Tap Water Iontophoresis Device
Published
2020-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGJDevice, Iontophoresis, Other Uses

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGJDevice, Iontophoresis, Other UsesPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250571300818PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250571300818042505713008184250571300818

GMDN Terms#

Term, Definition table
TermDefinition
Hyperhidrosis iontophoresis systemAn assembly of mains electricity (AC-powered) devices intended to be used to transport ions in tap water (water from a faucet) and/or a water solution (e.g., glycopyrrolate and aluminium chloride) to the sweat ducts of heavy sweating areas of the body (e.g., hands, underarms, or feet) in patients that suffer from excessive perspiration (hyperhidrosis) to help minimize or stop sweating. Hyperkeratotic plugs develop in the sweat ducts as a result of the currents and hyperhidrosis is controlled.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-322-8546thartman@daavlin.com
1-800-322-8546info@daavlin.com

Regulatory Flags#

DUNS number
326742426
Device count
1
Premarket exempt
true
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250571300832PhotheraAquex (HPRO10)PHO1000K2025-01-07
04250571300610HIDREX USADVP1000 Package HF ALION17110US2017-02-08
04250571300719HIDREX USADP450 Package HF ALION17451US2017-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10768627016497Push Patch Controlled Released 12.0NORTH COAST MEDICAL, INC.EGJ2025-12-01
00768627016995PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
00768627016988PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
20768627016494Push Patch Controlled Released 12.0NORTH COAST MEDICAL, INC.EGJ2025-12-01
10768627016299ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016305ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016312ActivaTek Ionto4 ButterflyNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016282ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016296ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016302ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016319ActivaTek Ionto4 ButterflyNORTH COAST MEDICAL, INC.EGJ2025-04-02
04250571300832PhotheraHIDREX GmbHEGJ2025-01-07
08054383090006MATTIOLIMATTIOLI ENGINEERING ITALIA SPAEGJ2024-09-26
00850030915047Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915078Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915108Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915252RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915269RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915276RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915283RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915290RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915306RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915313RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915320RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915337RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915344RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915351RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915368RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915016Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915054Dupel BLUESouth Dakota Partners Inc.EGJ2023-08-02