AccessGUDID - DEVICE: Moore Tracheostomy Tube (14063107102414)

GUDID

Device Identifier (DI) Information

Brand Name: Moore Tracheostomy Tube
Version or Model: MTT-010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MTT-010
Company Name: Boston Medical Products, Inc.

Primary DI Number: 14063107102414
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 10; Type: Radiopaque

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:	No
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?
38792	Tracheostomy tube, non-reinforced, non-customized, reusable	A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTO	Tube, Tracheostomy (W/Wo Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962240	000

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size: 10
Outer Diameter: 13 Millimeter
Length: 115 Millimeter
Lumen/Inner Diameter: 8.4 Millimeter

Device Record Status

Public Device Record Key: fd5f0439-ba86-4e24-8a06-6e1e39f87132
Public Version Date: September 08, 2022
Public Version Number: 1
DI Record Publish Date: August 31, 2022