AccessGUDID - DEVICE: Model 1620 AC Recharger (00857334004200)

GUDID

Device Identifier (DI) Information

Brand Name: Model 1620 AC Recharger
Version or Model: 1620
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1620
Company Name: Reshape Lifesciences Inc.

Primary DI Number: 00857334004200
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 1620 AC Recharger is a non-sterile external power supply that connects to a power outlet for use in charging the battery within the Mobile Charger.

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?
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	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 Atmospheric Pressure: between 70 and 150 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 9.5 Inch

Device Record Status

Public Device Record Key: f0da9ec9-56fb-49a8-bd08-8b966830699c
Public Version Date: July 28, 2023
Public Version Number: 7
DI Record Publish Date: April 17, 2015