AccessGUDID - DEVICE: Busse Hospital Disposables (00849233011069)

GUDID

Device Identifier (DI) Information

Brand Name: Busse Hospital Disposables
Version or Model: 9251
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9251
Company Name: ROBERT BUSSE & CO., INC.

Primary DI Number: 00849233011069
Issuing Agency: GS1
Commercial Distribution End Date: March 17, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 002418234 *Terms of Use

Device Description: Tracheostomy Care Tray

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:	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?
14090	Tracheostomy care kit, single-use	A collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXA	Tracheotomy Care Kit

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: 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: f991a13a-5c9a-4c87-af5e-dc1d8b766e55
Public Version Date: March 18, 2026
Public Version Number: 3
DI Record Publish Date: April 08, 2020