AccessGUDID - DEVICE: DISPOSABLE BALLOON CATHETER (04953170047442)

GUDID

Device Identifier (DI) Information

Brand Name: DISPOSABLE BALLOON CATHETER
Version or Model: B7-2Q
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170047442
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: DISPOSABLE BALLOON CATHETER

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?
65545	Gastrointestinal/tracheobronchial balloon catheter	A multi-purpose flexible tube with an inflatable balloon at the distal end designed to be introduced into either the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) or tracheobronchial tree (i.e., capable of both) for the injection/irrigation of fluids (e.g., contrast medium), removal of foreign bodies (e.g., biliary stones, food), and control of bleeding. It typically has more than one lumen and port for the separate introduction of fluids and air, and is introduced via a flexible endoscope. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGE	CATHETER, BILIARY, DIAGNOSTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962925	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: e6636739-bd61-4a4f-9a61-7bda6bc2bb2b
Public Version Date: April 22, 2024
Public Version Number: 6
DI Record Publish Date: September 21, 2016