Guardio

Basic Information

• Brand Name: Guardio
• Primary DI: 00810003380074
• Version / Model: Guardio Charger System
• Catalog Number: 10-F311-3-XX
• Company Name: Impulse Dynamics (usa) Inc.
• Labeler DUNS: 878519342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-27
• Public Version: 1
• Public Version Date: 2023-04-04
• Public Version Status: New
• Public Device Record Key: 114126cb-3e30-4f1f-b103-49981745a889

Device Description

Guardio Charger System consists of: (1) Guardio Charger (1) Battery Charger (1) EU Plug Adapter (1) US Plug Adapter (1) Manual Insert

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QFV	Implantable Pulse Generator	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
33658	Implant battery charger	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810003380074	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P180036	007

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit