ARTERIAL LINE DRESSING CHANGE KIT

Basic Information

• Brand Name: ARTERIAL LINE DRESSING CHANGE KIT
• Primary DI: M752HCT900CHX0
• Version / Model: HCT900CHX
• Company Name: STRADIS MEDICAL LLC
• Labeler DUNS: 043537671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-10
• Public Version: 1
• Public Version Date: 2022-01-18
• Public Version Status: New
• Public Device Record Key: e7f3e626-c540-42da-8dd9-51d0937f0782

Device Description

PREP INF DOSE NEW OR REPLACEMENT DRESSING AND FLUSING OF LINE

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
PEZ	Central Venous Catheter Dressing Change Kit	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61345	Arterial/central venous catheterization support/maintenance kit, non-medicated	A collection of devices 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 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, catheter introduction device, nor pharmaceuticals 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
Primary	M752HCT900CHX0	HIBCC
Package	M752HCT900CHX5	HIBCC	outer box	30	In Commercial Distribution

Customer Contacts

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