OBALON® Balloon System

GUDID 10859810006057

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

OBALON THERAPEUTICS, INC.

Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon
Primary Device ID10859810006057
NIH Device Record Keyd6161536-099c-42f8-a781-08cbb9e502fb
Commercial Distribution Discontinuation2017-07-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOBALON® Balloon System
Version Model Number9500-0001
Company DUNS022894714
Company NameOBALON THERAPEUTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com
Phone1-844-362-2566
Emailcustomerservice@obalon.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)

Device Identifiers

Device Issuing AgencyDevice ID
GS100859810006050 [Primary]
GS110859810006057 [Package]
Contains: 00859810006050
Package: [5 Units]
Discontinued: 2017-07-12
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LTIImplant, Intragastric For Morbid Obesity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-07-12
Device Publish Date2016-12-26

Devices Manufactured by OBALON THERAPEUTICS, INC.

00859810006197 - OBALON®2020-02-06 OBALON® Reference Sensor Cable - component for use with the OBALON® Navigation Console
20859810006269 - Obalon Aspiration Adapter2019-11-08 Aspiration adapter
00859810006104 - OBALON Touch™ 2019-03-11 OBALON Touch™ Dispenser - component to inflate the OBALON® Balloon
00859810006142 - OBALON®2019-03-11 OBALON® Accessory Kit - Ejectors - component for use with the OBALON® Balloon
00859810006173 - OBALON®2019-03-11 OBALON® Balloon Evacuator - component for use with the OBALON® Balloon
00859810006180 - OBALON®2019-03-11 OBALON® Navigation Console - component to visualize the OBALON® Balloon
00859810006203 - OBALON Touch™2019-03-11 OBALON Touch™ Dispenser Kit - contains one OBALON Touch™ Dispenser, one OBALON® Balloon Evacuator, 1 Screwdriver, and Batte
10859810006224 - OBALON®2019-03-11 OBALON® Navigation Balloon System - contains one OBALON® Navigation Balloon Kit and one OBALON® Accessory Kit - Ejectors

Trademark Results [OBALON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OBALON
OBALON
77416644 4067456 Live/Registered
Obalon Therapeutics, Inc.
2008-03-07

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