AccessGUDID - DEVICE: Montgomery® Cannula Speaking Valve (14063107100939)

GUDID

Device Identifier (DI) Information

Brand Name: Montgomery® Cannula Speaking Valve
Version or Model: 350401
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 350401
Company Name: Boston Medical Products, Inc.

Primary DI Number: 14063107100939
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 4; Type: Silicone

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?
36071	Tracheostomy tube speech valve	A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOH	Tube Tracheostomy And Tube Cuff

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K955516	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: Size: 4

Device Record Status

Public Device Record Key: b116e265-aeef-4df7-8489-6c36e271f0f0
Public Version Date: October 07, 2022
Public Version Number: 1
DI Record Publish Date: September 29, 2022