AccessGUDID - DEVICE: OBALON Touch™ (00859810006104)

GUDID

Device Identifier (DI) Information

Brand Name: OBALON Touch™
Version or Model: 4300-0003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ReShape Lifesciences Inc.

Primary DI Number: 00859810006104
Issuing Agency: GS1
Commercial Distribution End Date: March 02, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 022894714 *Terms of Use

Device Description: OBALON Touch™ Dispenser - component to inflate the OBALON® Balloon

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
63320	Appetite-suppression gastric balloon inflation regulator	A battery-powered device intended to regulate the flow of a medical gas (e.g., nitrogen-sulphur hexafluoride) from a small gas canister into an appetite-suppression gastric balloon (not included) during in situ balloon inflation. It is an electronic regulator designed to accept the gas canister (not included), and intended to be connected to the balloon via appropriate tubing/catheter (not included). This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Operating Altitude Limits: between 0 and 8000 Feet
Special Storage Condition, Specify: Keep Dry
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9d35cbca-5a32-4df8-8742-bd57b01fe43d
Public Version Date: July 18, 2025
Public Version Number: 4
DI Record Publish Date: February 20, 2019