AccessGUDID - DEVICE: Stronghold (00860002529011)

GUDID

Device Identifier (DI) Information

Brand Name: Stronghold
Version or Model: ADD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ADD
Company Name: HAMMER-PLANE INC

Primary DI Number: 00860002529011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791765001 *Terms of Use

Device Description: Stronghold anti-disconnect device accommodating Adult tracheostomy tubes with a 1 inch neck flange

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
63438	Tracheostomy tube neck holder, single-use	A non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAY	Support, Breathing Tube

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 49f6019d-e357-4d40-9ea6-611f62e453e4
Public Version Date: October 04, 2019
Public Version Number: 1
DI Record Publish Date: September 26, 2019