OBALON®

GUDID 00859810006234

OBALON® Navigation Balloon Kit - Intragastric Balloon

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 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 ID00859810006234
NIH Device Record Key86b8baf4-4a46-4599-aa8e-548d8eeb389e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOBALON®
Version Model Number7410-0001
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
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

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100859810006234 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-20

On-Brand Devices [OBALON®]

00859810006241OBALON® Recalibration Tool - component for use with the OBALON® Navigation Console
00859810006234OBALON® Navigation Balloon Kit - Intragastric Balloon
10859810006224OBALON® Navigation Balloon System - contains one OBALON® Navigation Balloon Kit and one OBALON
00859810006197OBALON® Reference Sensor Cable - component for use with the OBALON® Navigation Console
00859810006180OBALON® Navigation Console - component to visualize the OBALON® Balloon
00859810006173OBALON® Balloon Evacuator - component for use with the OBALON® Balloon
00859810006142OBALON® Accessory Kit - Ejectors - component for use with the OBALON® Balloon

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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