AccessGUDID - DEVICE: ReShape Lap-Band® 2.0, FLEX Tubing Kit (00850007764586)

GUDID

Device Identifier (DI) Information

Brand Name: ReShape Lap-Band® 2.0, FLEX Tubing Kit
Version or Model: D-3500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D-3500
Company Name: ReShape Lifesciences Inc.

Primary DI Number: 00850007764586
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022894714 *Terms of Use

Device Description: ReShape Lap-Band® 2.0, FLEX Tubing Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47066	Gastric band repair kit	A collection of sterile devices designed to repair an inflatable gastric band that deflates due to a leakage around the original connector or in the original tubing. It typically includes replacement silicone tubing, stainless steel connectors, a priming needle and an end plug. It may be used during the repositioning or relocating of the access port. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LTI	Implant, Intragastric For Morbid Obesity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000008	048

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not use if package is damaged and consult instructions for use

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 307dd0d2-40a0-49e8-bfdd-609b5e324e50
Public Version Date: July 18, 2025
Public Version Number: 2
DI Record Publish Date: January 22, 2024