AccessGUDID - DEVICE: Moore Tube 15 mm Inner Cannula (EBESMTT008CN0)

GUDID

Device Identifier (DI) Information

Brand Name: Moore Tube 15 mm Inner Cannula
Version or Model: MTT-008-CN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MTT-008-CN
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBESMTT008CN0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 8; 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:	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?
45920	Tracheostomy tube cannula, reusable	A hollow, cylindrical, curved device designed as an internal, independent component of a metal tracheostomy tube. It is made of metal [e.g., high-grade stainless steel and/or silver (Ag) or silver plated brass] or plastic and has precise dimensions allowing it to fit exactly into the outer tube and function as the inner cannula for tracheostomy tubes that have this kind of function. It is removed once or more times daily to facilitate the removal of phlegm, slime, and contamination build-up, thereby preventing blockage and infection of the stoma and eliminates the traumatic removal of the tracheostomy tube. 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 dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size: 8

Device Record Status

Public Device Record Key: 93ed9ca9-dd9a-4844-b4b1-eb2a7a5162fa
Public Version Date: August 30, 2022
Public Version Number: 4
DI Record Publish Date: September 20, 2015