GIBI HD B-2036

GUDID 00850007764227

Gastrointestinal Boundary Identification and Sizing Tube 36 French

Reshape Lifesciences Inc.

Gastric calibration tube, non-sterile
Primary Device ID00850007764227
NIH Device Record Key44f37904-6791-439a-a6ae-23a86878a0a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameGIBI HD
Version Model NumberB-2036
Catalog NumberB-2036
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007764227 [Primary]

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 Date2022-08-15
Device Publish Date2022-08-07

On-Brand Devices [GIBI HD]

00850007764234Gastrointestinal Boundary Identification and Sizing Tube 40 French
00850007764227Gastrointestinal Boundary Identification and Sizing Tube 36 French
00850007764210Gastrointestinal Boundary Identification and Sizing Tube 32 French

Trademark Results [GIBI HD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GIBI HD
GIBI HD
97217392 not registered Live/Pending
Reshape Lifesciences, Inc.
2022-01-13

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