FDA.reportPublic FDA data

ReShape Calibration Tubes

Primary DI
00850007764265
Brand
ReShape Calibration Tubes
Company
Medtimo, Inc
Model
B-2036
Catalog number
B-2036
Device description
Calibration and Sizing Tube 36 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
K241039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230131000ReShape Calibration TubesReshape Lifesciences2023-02-15KNT
K241039000ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)Reshape Lifesciences2024-05-16KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850007764227PreviousGS10
00850007764265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007764227008500077642278500077642270850007764227
00850007764265008500077642658500077642650850007764265

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

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
No natural rubber latex
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
00850007764272ReShape Calibration TubesB-2040B-20402023-03-16
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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