Home GUDID 10859810006224 OBALON®
Primary DI 10859810006224
Brand OBALON®
Company OBALON THERAPEUTICS, INC.
Model 9410-0001
Device description OBALON® Navigation Balloon System - contains one OBALON® Navigation Balloon Kit and one OBALON® Accessory Kit - Ejectors
Published 2019-02-20
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile false
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 10859810006224 Package GS1 5 In Commercial Distribution 00859810006227 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 10859810006224 10859810006224 00859810006227 00859810006227 859810006227 0859810006227
GMDN Terms# Term, Definition table Term Definition Appetite-suppression gastric balloon deployment device/set A non-sterile, noninvasive device/collection of devices intended to be used in conjunction with an inflation regulator (not included) to support deployment of a gastric balloon in the stomach. It may include extension tubing, designed to connect the inflation regulator to the catheter, valves/connectors, or a balloon ejection syringe intended to inject fluid with enough pressure to disconnect the catheter from the balloon once fully inflated in situ; it includes at least one devices dedicated to appetite-suppression gastric balloon deployment. Neither the catheter nor balloon are included. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep dry Storage Environment Temperature 59 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 022894714 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# 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 00859810006234 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006241 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006210 OBALON® Inflation Can Medtimo, Inc LTI 2018-07-11
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