OBALON®

Basic Information

• Brand Name: OBALON®
• Primary DI: 00859810006197
• Version / Model: 7404-0001
• Company Name: Reshape Lifesciences Inc.
• Labeler DUNS: 022894714
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-20
• Public Version: 5
• Public Version Date: 2023-09-01
• Public Version Status: Update
• Public Device Record Key: 6e6b9843-b8da-459c-b979-17d1a3efc9c8
• Distribution End Date: 2020-03-02

Device Description

OBALON® Reference Sensor Cable - component for use with the OBALON® Navigation Console

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
LTI	Implant, Intragastric For Morbid Obesity	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
63341	Gastrointestinal catheter/endoscope tracking system sensor, body-surface	A noninvasive component of an electromagnetic (EM) catheter/endoscope tracking system intended to be placed on the skin surface as a reference for locating/tracking an internalized gastrointestinal catheter/endoscope. It includes a coil, which when placed within the EM field of the tracking system receives EM field data, sends a current back to the system (through induction) and allows for location to be acquired. It may be intended for use during catheter/endoscope tracking and/or for recalibration of another system sensor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859810006197	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity Noncondensing
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry