Resp-O2 Comfort-Foam Trach Tube Holder

Basic Information

• Brand Name: Resp-O2 Comfort-Foam Trach Tube Holder
• Primary DI: 00840117319219
• Version / Model: 35023
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-11
• Public Version: 1
• Public Version Date: 2022-05-19
• Public Version Status: New
• Public Device Record Key: 9996cda1-1eb9-4744-9e4a-122a4527c12d

Device Description

Resp-O2 Comfort-Foam Trach Tube Holder, X-Large, 1 PC, Adult & Bariatric, Neck 16"-24"/41-61 cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	868.5770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840117319219	GS1
Package	00840117319059	GS1	Box	12	In Commercial Distribution
Package	00840117319134	GS1	Case	5	In Commercial Distribution