AccessGUDID - DEVICE: Montgomery® Safe-T-Tube™ Plug/Ring Set (14063107102865)

GUDID

Device Identifier (DI) Information

Brand Name: Montgomery® Safe-T-Tube™ Plug/Ring Set
Version or Model: 361086
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 361086
Company Name: Boston Medical Products, Inc.

Primary DI Number: 14063107102865
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Tracheal T-Tube, 8/9 mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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 [?]
K843936	000

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 8/9 mm Montgomery® Safe-T-Tubes™

Device Record Status

Public Device Record Key: 926a92b4-dd1d-4696-8e47-e5d5b7b51e43
Public Version Date: October 07, 2024
Public Version Number: 1
DI Record Publish Date: September 28, 2024