AccessGUDID - DEVICE: Ballard* Turbo-Cleaning Closed Suction System (00609038989679)

GUDID

Device Identifier (DI) Information

Brand Name: Ballard* Turbo-Cleaning Closed Suction System
Version or Model: 98967
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22701356-5
Company Name: Avanos Medical, Inc.

Primary DI Number: 00609038989679
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: Turbo-Cleaning Closed Suction Catheter, T-Piece, WET PAK*

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
34923	Suction system catheter, general-purpose	A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSY	CATHETERS, SUCTION, TRACHEOBRONCHIAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Catheter Gauge: 14 French

Device Record Status

Public Device Record Key: ab9cfdd6-eee6-41d0-b449-c33d715a7839
Public Version Date: June 23, 2023
Public Version Number: 2
DI Record Publish Date: March 26, 2020