Pedi Tie

Basic Information

• Brand Name: Pedi Tie
• Primary DI: 00850014574055
• Version / Model: 301P
• Catalog Number: 301P
• Company Name: PEPPER MEDICAL INC.
• Labeler DUNS: 622637098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• 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: 247f5d67-b22c-4034-8da2-92f36387b5a8

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	00850014574055	GS1
Unit of Use	10850014574052	GS1

Customer Contacts

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