FDA.reportPublic FDA data

ReShape Calibration Tubes

Primary DI
00850007764272
Brand
ReShape Calibration Tubes
Company
Medtimo, Inc
Model
B-2040
Catalog number
B-2040
Device description
Calibration and Sizing Tube 40 French
Published
2023-03-16
Public version status
Update
Distribution status
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
K230131000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230131000ReShape Calibration TubesReshape Lifesciences2023-02-15KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850007764234PreviousGS10
00850007764272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007764234008500077642348500077642340850007764234
00850007764272008500077642728500077642720850007764272

GMDN Terms#

Term, Definition table
TermDefinition
Gastric calibration tubeA 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
Special Storage Condition, Specify00Do not use if package is damaged and consult instructions for use
Special Storage Condition, Specify00Do not use if package is damaged and consult instructions for use”

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
144843751
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
00850007764470ReShape Calibration Tubes™B-2017B-20172025-08-01
00850007764258ReShape Calibration TubesB-2032B-20322023-03-16
00850007764265ReShape Calibration TubesB-2036B-20362023-03-16
00850007764203Gastric Balloon Suction Catheter B-2020 B-2020 2020-11-01
00859810006005OBALON® Placebo Capsule7150-00032016-12-12
00859810006012OBALON® EzFill™ Can8200-00012016-12-22
00859810006050OBALON® Balloon System9500-00012016-12-26
00859810006081OBALON® Placebo Capsule HPMC7650-00022017-07-11
00859810006210OBALON® Inflation Can8200-00012018-07-11
00859810006227OBALON®9410-00012019-02-20
00859810006265Obalon Aspiration Adapter6100-00042018-08-09
00850007764500ReShape Lap-Band® 2.0 FLEX, StandardD-3360D-33602024-01-22
00850007764517ReShape Lap-Band® 2.0 FLEX, LargeD-3365D-33652024-01-22
00850007764548ReShape Lap-Band® 2.0, FLEX & Access Port, StandardD-3304D-33042024-01-22
00850007764555ReShape Lap-Band® 2.0, FLEX & Access Port, LargeD-3306D-33062024-01-22
00850007764586ReShape Lap-Band® 2.0, FLEX Tubing KitD-3500D-35002024-01-22
10850007764323LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.)B-20302-10B-20302-102021-04-01
10850007764330LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)B-20301-10B-20301-102021-04-01
00850007764043RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System StandardC-2304C-23042021-02-01
00850007764067RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System LargeC-2306C-23062021-02-01

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