AccessGUDID - DEVICE: Protocol Administration Set With Flexi-Cuff Retention Tip (10815112020160)

GUDID

Device Identifier (DI) Information

Brand Name: Protocol Administration Set With Flexi-Cuff Retention Tip
Version or Model: 390401
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 390401
Company Name: Bracco Diagnostics Inc.

Primary DI Number: 10815112020160
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 849234661 *Terms of Use

Device Description: Protocol Administration Set With Flexi-Cuff Retention Tip CO2 Delivery System for Colon Insufflation

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):	No
Device labeled as "Not made with natural rubber latex":	Yes
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?
38559	Insufflation gas conditioning tubing set	A collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device.	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 [?]
K030854	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 48 French

Device Record Status

Public Device Record Key: 56781b1b-ccdb-42f8-abd8-b8919ebe00bd
Public Version Date: May 26, 2025
Public Version Number: 5
DI Record Publish Date: September 19, 2016