AccessGUDID - DEVICE: 15 mm Adaptor (EBES3211570)

GUDID

Device Identifier (DI) Information

Brand Name: 15 mm Adaptor
Version or Model: 321157
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 321157
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBES3211570
Issuing Agency: HIBCC
Commercial Distribution End Date: April 15, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 15 Hebeler x 15 mm

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):	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?
47119	Tracheostomy tube decannulation cap	A device designed to facilitate tracheostomy tube weaning and removal (decannulation), as well as voice restoration, for patients who have been chronic users of a tracheostomy tube. It is a small plastic cover (a cap), typically brightly coloured for easy identification, that is placed on the proximal end of a fenestrated or uncuffed tracheostomy tube to close the tracheostomy termination. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTR	Tube, Tracheal (W/Wo Connector)

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: 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: Fits Size 15 mm Hebeler Safe-T-Tubes™

Device Record Status

Public Device Record Key: a76157b0-7ee5-426f-bbec-86f2f0a59076
Public Version Date: August 30, 2022
Public Version Number: 3
DI Record Publish Date: September 20, 2015