AccessGUDID - DEVICE: OBALON Touch™ (00859810006203)

GUDID

Device Identifier (DI) Information

Brand Name: OBALON Touch™
Version or Model: 9300-0001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Reshape Lifesciences Inc.

Primary DI Number: 00859810006203
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 Kit - contains one OBALON Touch™ Dispenser, one OBALON® Balloon Evacuator, 1 Screwdriver, and Batteries

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
63405	Appetite-suppression gastric balloon deployment device/set	A non-sterile, noninvasive device/collection of devices intended to be used in conjunction with an inflation regulator (not included) to support deployment of a gastric balloon in the stomach. It may include extension tubing, designed to connect the inflation regulator to the catheter, valves/connectors, or a balloon ejection syringe intended to inject fluid with enough pressure to disconnect the catheter from the balloon once fully inflated in situ; it includes at least one devices dedicated to appetite-suppression gastric balloon deployment. Neither the catheter nor balloon are included. This is a single-use 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: Keep dry
Storage Environment Temperature: between 39 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b09817e5-8c3d-4c0c-8516-8d68ebe5bbb8
Public Version Date: September 01, 2023
Public Version Number: 3
DI Record Publish Date: February 20, 2019