AccessGUDID - DEVICE: Two Tank Shuttle Valve System (30815112020782)

GUDID

Device Identifier (DI) Information

Brand Name: Two Tank Shuttle Valve System
Version or Model: 710602
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 710602
Company Name: Bracco Diagnostics Inc.

Primary DI Number: 30815112020782
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 849234661 *Terms of Use

Device Description: Two Tank Shuttle Valve 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":	Yes
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?
41617	Gastrointestinal endoscopic insufflator	A mains electricity (AC-powered) device intended to be used during an endoscopic procedure to distend (expand by pressure) the lumen of the colon or other portion of the gastrointestinal (GI) tract, and/or improve endoscopic visualization (e.g., prevent dew/mist accumulating at the lens) through the pressure-limited introduction of medical gas [e.g., carbon dioxide (CO2)]. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. This device may also be referred to as a gas distention system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4f008043-3f68-4b91-8d08-917c55ebed7d
Public Version Date: May 26, 2025
Public Version Number: 3
DI Record Publish Date: September 19, 2016