AccessGUDID - DEVICE: OBALON® Inflation Can (00859810006210)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00859810006210
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® Inflation 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?
63343	Appetite-suppression gastric balloon inflation gas cartridge	A small container prefilled with a mixture of medical grade sulphur hexafluoride (SF6) and nitrogen at high pressure intended to be used with a dedicated regulator to inflate an appetite-suppression gastric balloon in situ (i.e., in the stomach). It is a metal device with a valve, and is not intended to be refilled. 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 Altitude: 0 to 12,000ft (0 to 3,658m), Storage Temperature Limits: 32 to 104 degrees F (0 to 40 degrees C)
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ba7ce5d-2d12-48c2-aae7-e2c361fb1bda
Public Version Date: September 01, 2023
Public Version Number: 3
DI Record Publish Date: July 11, 2018