AccessGUDID - DEVICE: Dale 200 One Piece Holder (H84102001)

GUDID

Device Identifier (DI) Information

Brand Name: Dale 200 One Piece Holder
Version or Model: 200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 200
Company Name: Dale Medical Products, Inc.

Primary DI Number: H84102001
Issuing Agency: HIBCC
Commercial Distribution End Date: August 05, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 001061233 *Terms of Use

Device Description: Dale One Piece tracheostomy tube holder, 1" wide neckband, fits 9.5" to 18" neck.

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):	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?
35752	Tracheostomy tube neck holder, reusable	A 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 reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBH	Device, Fixation, Tracheal 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: e9255e5b-2591-46f9-a8ab-3e5e35786ce8
Public Version Date: April 22, 2024
Public Version Number: 4
DI Record Publish Date: August 27, 2018