AccessGUDID - DEVICE: OBALON® EzFill™ Can (00859810006012)

GUDID

Device Identifier (DI) Information

Brand Name: OBALON® EzFill™ Can
Version or Model: 8200-0001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ReShape Lifesciences Inc.

Primary DI Number: 00859810006012
Issuing Agency: GS1
Commercial Distribution End Date: August 17, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 022894714 *Terms of Use

Device Description: OBALON® EzFill™ Can - component to inflate the OBALON® Balloon System

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:	Yes
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?
17202	Appetite-suppression gastric balloon	An implantable device intended to be swallowed or endoscopically inserted into the stomach where it is inflated to reduce stomach volume and facilitate weight loss in overweight/obese patients by restricting the quantity of food consumed through an increased sense of satiety (fullness). It is designed to be inflated/filled with an inert material (e.g., saline, air, nitrogen) in situ, where it remains until it is endoscopically removed or deflates and passes through the bowels. Disposable devices dedicated to introduction/inflation may be included with the balloon.	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 [?]
P160001	000

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
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 30 and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep Dry, Storage Altitude: 0 to 12,000ft (0 to 3,658m), Storage Temperature Limits: 32 to 104 degrees F (0 to 40 degrees C)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 439dee7b-7e0a-4ece-819a-c7d5ec023aff
Public Version Date: July 18, 2025
Public Version Number: 8
DI Record Publish Date: December 22, 2016