Stradis Medical, LLC.

Basic Information

• Brand Name: Stradis Medical, LLC.
• Primary DI: M752HCT8249CP3B0
• Version / Model: HCT8249CP-3B
• Company Name: STRADIS MEDICAL LLC
• Labeler DUNS: 043537671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-22
• Public Version: 1
• Public Version Date: 2021-03-02
• Public Version Status: New
• Public Device Record Key: 6f2fbd29-33e4-40e9-b467-1ce01b3910ed

Device Description

Child's Central Line Insertion Tray

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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OFF	Central Venous Catheter Tray	Cardiovascular	870.1140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65100	Arterial/central venous catheterization support/maintenance kit, medicated	A collection of devices which includes a pharmaceutical agent intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Primarily intended to be used at the patient’s bedside, the kit includes [in addition to the pharmaceutical agent(s)] devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution; neither the catheter nor catheter introduction device are included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M752HCT8249CP3B5	HIBCC	Outer Box	12	In Commercial Distribution
Primary	M752HCT8249CP3B0	HIBCC

Customer Contacts

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