AccessGUDID - DEVICE: Trach Tube Cleaning Brushes (EBES33061)

GUDID

Device Identifier (DI) Information

Brand Name: Trach Tube Cleaning Brushes
Version or Model: 3306
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3306
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBES33061
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 6

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":	No
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?
58718	Tracheostomy tube cannula cleaning swab, non-sterile	A non-sterile device intended to be used to clean the inner cannula of a tracheostomy tube that has been removed from the in situ tracheostomy tube. It typically consists of a flexible shaft, which in itself can act as a handle, with a swab made of foam or bristles at the distal end. It is used by a patient or healthcare provider to remove secretions from the inside of the inner cannula. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EPE	Brush, Cleaning, Tracheal Tube

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
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size: 6

Device Record Status

Public Device Record Key: a28e3bea-b459-460e-98cb-cae498ed6a22
Public Version Date: August 30, 2022
Public Version Number: 3
DI Record Publish Date: September 20, 2015