AccessGUDID - DEVICE: Montgomery® Safe-T-Tube™ (14063107103411)

GUDID

Device Identifier (DI) Information

Brand Name: Montgomery® Safe-T-Tube™
Version or Model: 560015R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 560015R
Company Name: Boston Medical Products, Inc.

Primary DI Number: 14063107103411
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, Thoracic, 15 mm, 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:	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?
35458	Trachea prosthesis	An implantable artificial substitute for the natural trachea used in airway reconstructive surgery. It is typically a semi-rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal trachea prosthesis may be uncovered or covered with a polymeric material.	Active	true

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: 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: Length (Outer Limb): 65 mm
Device Size Text, specify: Outer Diameter (Outer Limb): 15 mm
Device Size Text, specify: Length (Lower Inner Limb): 80 mm
Device Size Text, specify: Length (Upper Inner Limb): 28 mm
Device Size Text, specify: Length (Inner Limb): 122 mm
Device Size Text, specify: Outer Diameter (Inner Limb): 14 mm

Device Record Status

Public Device Record Key: 55355134-33fe-4167-9f91-511f30353b07
Public Version Date: October 07, 2024
Public Version Number: 1
DI Record Publish Date: September 28, 2024