Model 2404 Maestro Patient Kit

Basic Information

• Brand Name: Model 2404 Maestro Patient Kit
• Primary DI: 00857334004347
• Version / Model: 2404
• Catalog Number: 2404
• Company Name: Reshape Lifesciences Inc.
• Labeler DUNS: 144998551
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-04-17
• Public Version: 6
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: f3155d2d-535e-4238-b02d-25933379e118
• Distribution End Date: 2020-09-01

Device Description

The Model 2404 Patient Kit consists of a Model 2402 Mobile Charger, a Model 2403-60 Patient Transmit Coil, a Model 1620 AC Recharger, and a Model 1660 Patient Transmit Coil Belt that are packaged together.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
PIM	neuromodulator for obesity	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
64411	Implant battery charger/performance analyser	An electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ, in addition to measuring elements of the status of the implant (e.g., temperature, battery voltage). It may also display alert messages concerning that status to the patient.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857334004347	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P130019	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 150 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius