Home GUDID 00859810006050 OBALON® Balloon System
Primary DI 00859810006050
Brand OBALON® Balloon System
Company Medtimo, Inc
Model 9500-0001
Device description OBALON® Balloon System - contains one Obalon Balloon Kit and one Obalon Accessory Kit
Published 2016-12-26
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
Single use true Product Codes# Code, Name table Code Name LTI Implant, Intragastric For Morbid Obesity
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LTI Implant, Intragastric For Morbid Obesity Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10859810006057 Package GS1 5 Not in Commercial Distribution 00859810006050 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10859810006057 10859810006057 00859810006050 00859810006050 859810006050 0859810006050
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C) Storage Environment Temperature 59 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 144843751 Device count 1 Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850007764470 ReShape Calibration Tubes™ B-2017 B-2017 2025-08-01 00850007764258 ReShape Calibration Tubes B-2032 B-2032 2023-03-16 00850007764265 ReShape Calibration Tubes B-2036 B-2036 2023-03-16 00850007764272 ReShape Calibration Tubes B-2040 B-2040 2023-03-16 00850007764203 Gastric Balloon Suction Catheter B-2020 B-2020 2020-11-01 00859810006005 OBALON® Placebo Capsule 7150-0003 2016-12-12 00859810006012 OBALON® EzFill™ Can 8200-0001 2016-12-22 00859810006081 OBALON® Placebo Capsule HPMC 7650-0002 2017-07-11 00859810006210 OBALON® Inflation Can 8200-0001 2018-07-11 00859810006227 OBALON® 9410-0001 2019-02-20 00859810006265 Obalon Aspiration Adapter 6100-0004 2018-08-09 00850007764500 ReShape Lap-Band® 2.0 FLEX, Standard D-3360 D-3360 2024-01-22 00850007764517 ReShape Lap-Band® 2.0 FLEX, Large D-3365 D-3365 2024-01-22 00850007764548 ReShape Lap-Band® 2.0, FLEX & Access Port, Standard D-3304 D-3304 2024-01-22 00850007764555 ReShape Lap-Band® 2.0, FLEX & Access Port, Large D-3306 D-3306 2024-01-22 00850007764586 ReShape Lap-Band® 2.0, FLEX Tubing Kit D-3500 D-3500 2024-01-22 10850007764323 LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.) B-20302-10 B-20302-10 2021-04-01 10850007764330 LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.) B-20301-10 B-20301-10 2021-04-01 00850007764043 RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Standard C-2304 C-2304 2021-02-01 00850007764067 RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Large C-2306 C-2306 2021-02-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00191506049232 Orbera™ BOSTON SCIENTIFIC CORPORATION LTI 2026-06-04 00810010540119 Allurion™ Gastric Balloon System Allurion Technologies, Inc. LTI 2026-04-07 00810010540126 Allurion™ Filler Kit Allurion Technologies, Inc. LTI 2026-04-07 00810010540133 Allurion™ Stylet Allurion Technologies, Inc. LTI 2026-04-07 03665039001663 Endoline PUNC PRINCE MEDICAL LTI 2024-01-30 03665039005630 Extraction Kit PRINCE MEDICAL LTI 2024-01-30 00850007764500 ReShape Lap-Band® 2.0 FLEX, Standard Medtimo, Inc LTI 2024-01-22 00850007764517 ReShape Lap-Band® 2.0 FLEX, Large Medtimo, Inc LTI 2024-01-22 00850007764548 ReShape Lap-Band® 2.0, FLEX & Access Port, Standard Medtimo, Inc LTI 2024-01-22 00850007764555 ReShape Lap-Band® 2.0, FLEX & Access Port, Large Medtimo, Inc LTI 2024-01-22 00850007764586 ReShape Lap-Band® 2.0, FLEX Tubing Kit Medtimo, Inc LTI 2024-01-22 00860005178803 Spatz3 Adjustable Balloon System insertion kit SPATZ FGIA (ISRAEL) LTD LTI 2021-10-20 10850007764323 LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.) Medtimo, Inc LTI 2021-04-01 10850007764330 LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.) Medtimo, Inc LTI 2021-04-01 00850007764043 RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Standard Medtimo, Inc LTI 2021-02-01 00850007764067 RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Large Medtimo, Inc LTI 2021-02-01 00850007764609 LAP-BAND® AP System Standard with RapidPort® EZ Medtimo, Inc LTI 2021-02-01 00850007764654 LAP-BAND® AP System Large with RapidPort® EZ Medtimo, Inc LTI 2021-02-01 00850007764906 RapidPort® EZ Port Applier Medtimo, Inc LTI 2021-01-01 00850007764173 LAP-BAND® System Calibration Tube ReShape Lifesciences Inc. LTI 2020-12-01 00859810006227 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006104 OBALON Touch™ Medtimo, Inc LTI 2019-02-20 00859810006142 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006173 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006180 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006197 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006203 OBALON Touch™ Medtimo, Inc LTI 2019-02-20 10859810006224 OBALON® OBALON THERAPEUTICS, INC. LTI 2019-02-20 00859810006234 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006241 OBALON® Medtimo, Inc LTI 2019-02-20
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