AccessGUDID - DEVICE: Tracheostomy and Suction Accessory (00848530106348)

GUDID

Device Identifier (DI) Information

Brand Name: Tracheostomy and Suction Accessory
Version or Model: VEN004
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530106348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Active Exhalation Vlave Adapter with Pressure Tubing Comparable OEM# 1065659

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):	No
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?
62966	Artificial airway cuff inflation tubing	A length of flexible tube designed to connect cuff inflation devices to deliver air during inflation of the cuff of an endotracheal (ET)/ tracheostomy tube. It typically includes connectors at each end. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZA	Connector, Airway (Extension)

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: 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: 4bd8c1e4-7fa4-4b79-8588-a853c000ebca
Public Version Date: July 10, 2025
Public Version Number: 1
DI Record Publish Date: July 02, 2025