Pedi Tie

Basic Information

• Brand Name: Pedi Tie
• Primary DI: 10850014574403
• Version / Model: 501P
• Catalog Number: 501P
• Company Name: PEPPER MEDICAL INC.
• Labeler DUNS: 622637098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-17
• Public Version: 4
• Public Version Date: 2023-11-08
• Public Version Status: Update
• Public Device Record Key: 75e51a12-6831-4890-87ac-8b5df61d5a04

Device Description

Pedi Trach Tube Holder

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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	10850014574403	GS1
Package	00850014574130	GS1	Box	20	In Commercial Distribution

Customer Contacts

• Phone: [phone] ext. 2
• Email: [email protected]