Gastric Balloon Suction Catheter B-2020

GUDID 00850007764203

Bio Gastric Balloon Suction Catheter

Reshape Lifesciences Inc.

Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube, non-sterile Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube Gastric calibration tube
Primary Device ID00850007764203
NIH Device Record Keyaf963dc0-57bd-48fe-91a4-6d80647e89cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameGastric Balloon Suction Catheter
Version Model NumberB-2020
Catalog NumberB-2020
Company DUNS144998551
Company NameReshape Lifesciences Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com
Phone844-937-7374
EmailCustomerService@ReShapelifesci.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do Not Use if Package is Damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult instructions for use

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007764203 [Primary]
GS110811955020039 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-11-01

Devices Manufactured by Reshape Lifesciences Inc.

00850007764500 - ReShape Lap-Band® 2.0 FLEX, Standard2024-01-30 ReShape Lap-Band® 2.0 FLEX, Standard
00850007764517 - ReShape Lap-Band® 2.0 FLEX, Large2024-01-30 ReShape Lap-Band® 2.0 FLEX, Large
00850007764548 - ReShape Lap-Band® 2.0, FLEX & Access Port, Standard2024-01-30 ReShape Lap-Band® 2.0, FLEX & Access Port, Standard
00850007764555 - ReShape Lap-Band® 2.0, FLEX & Access Port, Large2024-01-30 ReShape Lap-Band® 2.0, FLEX & Access Port, Large
00850007764586 - ReShape Lap-Band® 2.0, FLEX Tubing Kit2024-01-30 ReShape Lap-Band® 2.0, FLEX Tubing Kit
00850007764258 - ReShape Calibration Tubes2023-03-24 Calibration and Sizing Tube 32 French
00850007764265 - ReShape Calibration Tubes2023-03-24 Calibration and Sizing Tube 36 French
00850007764272 - ReShape Calibration Tubes2023-03-24 Calibration and Sizing Tube 40 French
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.