FDA.reportPublic FDA data

ReShape Lap-Band® 2.0, FLEX & Access Port, Standard

Primary DI
00850007764548
Brand
ReShape Lap-Band® 2.0, FLEX & Access Port, Standard
Company
Medtimo, Inc
Model
D-3304
Catalog number
D-3304
Device description
ReShape Lap-Band® 2.0, FLEX & Access Port, Standard
Published
2024-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LTIImplant, Intragastric For Morbid Obesity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTIImplant, Intragastric For Morbid ObesityUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000008048

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000008048LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEMMedtimo, Inc.2001-06-05LTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850007764548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007764548008500077645488500077645480850007764548

GMDN Terms#

Term, Definition table
TermDefinition
Gastric band access port kitA collection of sterile devices designed to establish a replacement access port for an implanted gastric band of the adjustable type that is invasively inflated. It typically includes access port needles, an access port, an end plug, a connector, and tubing to connect the new port to the existing gastric band. It is typically used when the original port must be removed due to leaks, infection, or contamination. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
Kit
true
Lot or batch
true
Serial number
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
00850007764265ReShape Calibration TubesB-2036B-20362023-03-16
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810010540119Allurion™ Gastric Balloon SystemAllurion Technologies, Inc.LTI2026-04-07
00810010540126Allurion™ Filler KitAllurion Technologies, Inc.LTI2026-04-07
00810010540133Allurion™ StyletAllurion Technologies, Inc.LTI2026-04-07
03665039001663Endoline PUNCPRINCE MEDICALLTI2024-01-30
03665039005630Extraction Kit PRINCE MEDICALLTI2024-01-30
00850007764500ReShape Lap-Band® 2.0 FLEX, StandardMedtimo, IncLTI2024-01-22
00850007764517ReShape Lap-Band® 2.0 FLEX, LargeMedtimo, IncLTI2024-01-22
00850007764555ReShape Lap-Band® 2.0, FLEX & Access Port, LargeMedtimo, IncLTI2024-01-22
00850007764586ReShape Lap-Band® 2.0, FLEX Tubing KitMedtimo, IncLTI2024-01-22
00860005178803Spatz3 Adjustable Balloon System insertion kit SPATZ FGIA (ISRAEL) LTDLTI2021-10-20
10850007764323LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.)Medtimo, IncLTI2021-04-01
10850007764330LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)Medtimo, IncLTI2021-04-01
00850007764043RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System StandardMedtimo, IncLTI2021-02-01
00850007764067RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System LargeMedtimo, IncLTI2021-02-01
00850007764609LAP-BAND® AP System Standard with RapidPort® EZ Medtimo, IncLTI2021-02-01
00850007764654LAP-BAND® AP System Large with RapidPort® EZ Medtimo, IncLTI2021-02-01
00850007764906RapidPort® EZ Port ApplierMedtimo, IncLTI2021-01-01
00850007764173LAP-BAND® System Calibration TubeReShape Lifesciences Inc.LTI2020-12-01
00859810006227OBALON®Medtimo, IncLTI2019-02-20
00859810006104OBALON Touch™ Medtimo, IncLTI2019-02-20
00859810006142OBALON®Medtimo, IncLTI2019-02-20
00859810006173OBALON®Medtimo, IncLTI2019-02-20
00859810006180OBALON®Medtimo, IncLTI2019-02-20
00859810006197OBALON®Medtimo, IncLTI2019-02-20
00859810006203OBALON Touch™Medtimo, IncLTI2019-02-20
10859810006224OBALON®OBALON THERAPEUTICS, INC.LTI2019-02-20
00859810006234OBALON®Medtimo, IncLTI2019-02-20
00859810006241OBALON®Medtimo, IncLTI2019-02-20
00859810006210OBALON® Inflation CanMedtimo, IncLTI2018-07-11
10859810006217OBALON® Inflation CanOBALON THERAPEUTICS, INC.LTI2018-07-11