OBALON® EzFill™ Dispenser

GUDID 00859810006029

OBALON® EzFill™ Dispenser - component to inflate the OBALON® Balloon System

OBALON THERAPEUTICS, INC.

Appetite-suppression gastric balloon
Primary Device ID00859810006029
NIH Device Record Keya0bddcde-c57a-4313-9639-dfbfe53c0a4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOBALON® EzFill™ Dispenser
Version Model Number4200-0001
Company DUNS022894714
Company NameOBALON THERAPEUTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -0.4 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry, Storage Temperature Limits: -0.40 to 131 degrees F (-18 to 55 degrees C)

Device Identifiers

Device Issuing AgencyDevice ID
GS100859810006029 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-12-22

Devices Manufactured by OBALON THERAPEUTICS, INC.

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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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