AccessGUDID - DEVICE: Montgomery® Safe-T-Tube™ (EBES32008R0)

GUDID

Device Identifier (DI) Information

Brand Name: Montgomery® Safe-T-Tube™
Version or Model: 32008R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 32008R
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBES32008R0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: Pediatric 8 mm; 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:	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 [?]
K930150	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: Angle (Upper Limb to Outer Limb): 70 degrees
Device Size Text, specify: Length (Outer Limb): 45 mm
Device Size Text, specify: Outer Diameter (Outer Limb): 8 mm
Device Size Text, specify: Length (Lower Inner Limb): 42 mm
Device Size Text, specify: Length (Upper Inner Limb): 46 mm
Device Size Text, specify: Length (Inner Limb): 96 mm
Device Size Text, specify: Outer Diameter (Inner Limb): 8 mm

Device Record Status

Public Device Record Key: e3674141-314b-4a20-a6b0-6607d5a5d193
Public Version Date: August 30, 2022
Public Version Number: 4
DI Record Publish Date: September 20, 2015