AccessGUDID - DEVICE: Balloon2 (04953170355738)

GUDID

Device Identifier (DI) Information

Brand Name: Balloon2
Version or Model: MH-304
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170355738
Issuing Agency: GS1
Commercial Distribution End Date: August 12, 2022
Device Count: 20
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
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?
61506	Ultrasound endoscope balloon, Hevea-latex	A sterile balloon-like cap made of Hevea natural rubber latex (NRL) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDT	duodenoscope and accessories, flexible/rigid
ODG	Endoscopic ultrasound system, gastroenterology-urology
FDS	Gastroscope and accessories, flexible/rigid
FDF	Colonoscope and accessories, flexible/rigid

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7868e947-526a-4697-8af5-d79e2c13ecd8
Public Version Date: January 16, 2023
Public Version Number: 5
DI Record Publish Date: September 21, 2016