OBALON® Balloon System HPMC

Basic Information

• Brand Name: OBALON® Balloon System HPMC
• Primary DI: 00859810006074
• Version / Model: 9600-0001
• Company Name: Reshape Lifesciences Inc.
• Labeler DUNS: 022894714
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-11
• Public Version: 7
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 35ef00f3-0d4b-4c50-9e53-f07a4005c6b7
• Distribution End Date: 2020-03-02

Device Description

OBALON® Balloon System HPMC - contains one Obalon Balloon Kit HPMC and one Obalon Accessory Kit

Device Characteristics

• Single Use: Yes
• 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 Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
17202	Appetite-suppression gastric balloon	An implantable device intended to be swallowed or endoscopically inserted into the stomach where it is inflated to reduce stomach volume and facilitate weight loss in overweight/obese patients by restricting the quantity of food consumed through an increased sense of satiety (fullness). It is designed to be inflated/filled with an inert material (e.g., saline, air, nitrogen) in situ, where it remains until it is endoscopically removed or deflates and passes through the bowels. Disposable devices dedicated to introduction/inflation may be included with the balloon.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859810006074	GS1
Package	10859810006071	GS1		5	Not in Commercial Distribution	2020-03-02

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P160001	003

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit