AccessGUDID - DEVICE: Montgomery® Initial Cannula Set (EBES3306001)

GUDID

Device Identifier (DI) Information

Brand Name: Montgomery® Initial Cannula Set
Version or Model: 330600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 330600
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBES3306001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 6. Contains one each of 330601 & 341006.

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":	Yes
For Single-Use:	Yes
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?
14093	Tracheostoma button	A hollow device intended to be used routinely by a patient to prevent the narrowing of a tracheostoma during intermittent use of their tracheostomy or laryngectomy tube. It is a cylindrical synthetic polymer device designed for minimal intrusion beyond the tracheostomal orifice into which it is placed. This is a reusable device.	Active	false
33906	Tracheotome	A knife-like, hand-held manual surgical instrument designed to cut an opening into the trachea (windpipe) through the anterior surface of the neck to create an artificial airway (tracheotomy). This is a reusable device.	Active	false

FDA Product Code

[?]

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

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: 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: Outer Diameter (Cannula): 11 mm
Device Size Text, specify: Size: 6
Device Size Text, specify: Length (Cannula): 101 mm
Device Size Text, specify: Outer Diameter (Fenestrator): 8 mm

Device Record Status

Public Device Record Key: 5fe7925a-e2f7-4278-8329-4dff72a862c7
Public Version Date: August 30, 2022
Public Version Number: 3
DI Record Publish Date: September 20, 2015