FDA.reportPublic FDA data

GIBI HD

Primary DI
00850007764227
Brand
GIBI HD
Company
Reshape Lifesciences Inc.
Model
B-2036
Catalog number
B-2036
Device description
Gastrointestinal Boundary Identification and Sizing Tube 36 French
Published
2022-08-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221898000Gastrointestinal Boundary Identifier (GIBI HD)Reshape Lifesciences2022-07-28KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850007764227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007764227008500077642278500077642270850007764227

GMDN Terms#

Term, Definition table
TermDefinition
Gastric calibration tube, non-sterileA non-sterile, thin, flexible, hollow cylinder with an inflatable balloon at the distal end designed to be inserted into a patient's stomach through the mouth and oesophagus to create and size a gastric pouch typically for a bariatric gastric surgical procedure (e.g., sleeve gastrectomy, gastric banding). The proximal end may include a check valve and connects to a syringe, typically included, intended to inflate the balloon to a predetermined volume; fluid suction/irrigation ports are provided at the distal end. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Use if Package is Damaged

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-937-7374CustomerService@ReShapelifesci.com

Regulatory Flags#

DUNS number
144998551
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007764173LAP-BAND® System Calibration TubeB-2017B-20172020-12-01
00850007764210GIBI HDB-2032B-20322022-08-07
00850007764234GIBI HDB-2040B-20402022-08-07
00857334004194Model 1600 Maestro Programmer Cable160016002015-04-17
00857334004200Model 1620 AC Recharger162016202015-04-17
00857334004217Model 1660 Maestro Patient Transmit Coil Belt166016602015-04-17
00857334004248Model 1680 Torque Wrench168016802015-04-17
00857334004262Model 2002 Maestro Rechargeable Neuroregulator200220022015-04-17
00857334004279Model 2004 Maestro Implant Kit200420042015-04-17
00857334004286Model 2200A-47E Maestro Anterior Lead2200A-47E2200A-47E2015-04-17
00857334004293Model 2200P-47E Maestro Posterior Lead2200P-47E2200P-47E2015-04-17
00857334004309Model 2402 Maestro Mobile Charger240224022015-04-17
00857334004316Model 2403-300 Maestro Clinician Transmit Coil2403-3002403-3002015-04-17
00857334004323Model 2403-60 Maestro Patient Transmit Coil2403-602403-602015-04-17
00857334004347Model 2404 Maestro Patient Kit240424042015-04-17
00857334004354Model 2502 Maestro Clinician Programmer250225022015-04-17
00857334004361Model 2504 Maestro Clinician Programmer Kit250425042015-04-17

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