AccessGUDID - DEVICE: Model 2404 Maestro Patient Kit (00857334004347)

GUDID

Device Identifier (DI) Information

Brand Name: Model 2404 Maestro Patient Kit
Version or Model: 2404
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2404
Company Name: Reshape Lifesciences Inc.

Primary DI Number: 00857334004347
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 144998551 *Terms of Use

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

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:	Yes
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 Atmospheric Pressure: between 70 and 150 KiloPascal
Storage Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f3155d2d-535e-4238-b02d-25933379e118
Public Version Date: July 28, 2023
Public Version Number: 6
DI Record Publish Date: April 17, 2015