AccessGUDID - DEVICE: Model 2402 Maestro Mobile Charger (00857334004309)

GUDID

Device Identifier (DI) Information

Brand Name: Model 2402 Maestro Mobile Charger
Version or Model: 2402
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2402
Company Name: Reshape Lifesciences Inc.

Primary DI Number: 00857334004309
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 144998551 *Terms of Use

Device Description: The Model 2402 Mobile Charger (MC) is a non-sterile external component that is powered by a rechargeable, lithium-ion battery. The MC charges the Rechargeable Neuroregulator (RNR) when connected to a Transmit Coil positioned over the RNR. The MC also provides communication between the Clinician Programmer and RNR to allow up and down loading of data, display battery charge levels, indicate proper positioning of the Transmit Coil, alert patient to fault conditions, and allow for inactivation of therapy and turning off the RNR if needed.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIM	neuromodulator for obesity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P130019	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Width: 4.7 Inch
Height: 1.2 Inch
Length: 2 Inch

Device Record Status

Public Device Record Key: d575342c-8fe1-4970-9f8d-c2cc6e7233ab
Public Version Date: July 28, 2023
Public Version Number: 6
DI Record Publish Date: April 17, 2015