FDA.reportPublic FDA data

Guardio

Primary DI
00810003380074
Brand
Guardio
Company
Impulse Dynamics (usa) Inc.
Model
Guardio Charger System
Catalog number
10-F311-3-XX
Device description
Guardio Charger System consists of:(1) Guardio Charger(1) Battery Charger(1) EU Plug Adapter(1) US Plug Adapter(1) Manual Insert
Published
2023-03-27
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
QFVImplantable Pulse Generator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFVImplantable Pulse GeneratorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180036007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180036007OPTIMIZER Smart SystemImpulse Dynamics (Usa), Inc.2019-03-21QFV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810003380074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810003380074008100033800748100033800740810003380074

GMDN Terms#

Term, Definition table
TermDefinition
Implant battery chargerAn electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ. It is not intended to program or extract data from (read) the implanted device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8453592389contact.us@impulse-dynamics.com

Regulatory Flags#

DUNS number
878519342
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810003380135VestaVesta Charger System (For OPTIMIZER Lite)10-F302-3-XX2024-02-26
00810003380081VestaVesta Charger System10-F301-3-XX2022-04-29
00810003380043OPTIMIZER™Mini Charger System10-F202-3-XX2020-12-28
00810003380029OPTIMIZER®Mini Charger System10-F202-3-US2019-04-12
00810003380142OPTIMIZERLite10-B502-3-XX2024-02-26
00810003380067IntelioIntelio Portable Programmer Unit10-A701-3-XX2022-04-29
00810003380098OPTIMIZERSmart Mini10-B501-3-XX2022-04-29
00810003380050OPTIMIZER™CCM X1010-B411-3-XX2020-12-28
00810003380005OPTIMIZER®CCM X1010-B411-3-US2019-04-12
00810003380012OMNI™ IIProgrammer System (with OMNI Smart Software)10-A604-3-US2019-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003380135VestaImpulse Dynamics (usa) Inc.QFV2024-02-26
00810003380142OPTIMIZERImpulse Dynamics (usa) Inc.QFV2024-02-26
00810003380067IntelioImpulse Dynamics (usa) Inc.QFV2022-04-29
00810003380081VestaImpulse Dynamics (usa) Inc.QFV2022-04-29
00810003380098OPTIMIZERImpulse Dynamics (usa) Inc.QFV2022-04-29
00810003380043OPTIMIZER™Impulse Dynamics (usa) Inc.QFV2020-12-28
00810003380050OPTIMIZER™Impulse Dynamics (usa) Inc.QFV2020-12-28
00810003380005OPTIMIZER®Impulse Dynamics (usa) Inc.QFV2019-04-12
00810003380012OMNI™ IIImpulse Dynamics (usa) Inc.QFV2019-04-12
00810003380029OPTIMIZER®Impulse Dynamics (usa) Inc.QFV2019-04-12