Model 1620 AC Recharger 1620

GUDID 00857334004200

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.

ENTEROMEDICS INC.

Noninvasive device battery charger

• Primary Device ID: 00857334004200
• NIH Device Record Key: f0da9ec9-56fb-49a8-bd08-8b966830699c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 1620 AC Recharger
• Version Model Number: 1620
• Catalog Number: 1620
• Company DUNS: 144998551
• Company Name: ENTEROMEDICS INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com
• Phone: +1(651)789-2681
• Email: lpritchard@enteromedics.com

Device Dimensions

• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch
• Length: 9.5 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857334004200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130019

FDA Product Code

• PIM: neuromodulator for obesity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2015-04-17

Devices Manufactured by ENTEROMEDICS INC.

• 00857334004200 - Model 1620 AC Recharger: 2020-02-06The 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.
• 00857334004200 - Model 1620 AC Recharger: 2020-02-06 The Model 1620 AC Recharger is a non-sterile external power supply that connects to a power outlet for use in charging the batte
• 00857334004194 - Model 1600 Maestro Programmer Cable: 2018-07-06 The Model 1600 Programmer Cable is a non-sterile external component that is used to provide connectivity between the Model 2502
• 00857334004217 - Model 1660 Maestro Patient Transmit Coil Belt: 2018-07-06 The Model 1660 Patient Transmit Coil Belt is a non-sterile, optional external accessory that may be used to assist in holding th
• 00857334004248 - Model 1680 Torque Wrench: 2018-07-06 The Model 1680 Torque Wrench is a sterile standard surgical wrench provided for use during the implant procedure to tighten the
• 00857334004262 - Model 2002 Maestro Rechargeable Neuroregulator: 2018-07-06 The Model 2002 Rechargeable Neuroregulator (RNR) is provided sterile for implantation and has a hermetic case enclosure with an
• 00857334004279 - Model 2004 Maestro Implant Kit: 2018-07-06 The Model 2004 Implant Kit consists of a Model 2002 Rechargeable Neuroregulator (including Model 1680 Torque Wrench), a Model 22
• 00857334004286 - Model 2200A-47E Maestro Anterior Lead: 2018-07-06 The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iri
• 00857334004293 - Model 2200P-47E Maestro Posterior Lead: 2018-07-06 The Model 2200P-47E Posterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/ir