Stradis Medical, LLC

Basic Information

• Brand Name: Stradis Medical, LLC
• Primary DI: M752L0105630
• Version / Model: L010563
• Company Name: STRADIS MEDICAL LLC
• Labeler DUNS: 043537671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-29
• Public Version: 1
• Public Version Date: 2019-09-06
• Public Version Status: New
• Public Device Record Key: 9fd63c3a-1967-41be-8db5-0572f81def38

Device Description

Pediatric Needle Cricothyrotomy Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
45926	Cricothyrotomy kit, single-use	A collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M752L0105635	HIBCC	outer box	50	In Commercial Distribution
Primary	M752L0105630	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]