Stradis Medical, LLC.

Basic Information

• Brand Name: Stradis Medical, LLC.
• Primary DI: M7521000221
• Version / Model: 100022
• Company Name: STRADIS MEDICAL, LLC
• Labeler DUNS: 174262477
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-08
• Public Version: 3
• Public Version Date: 2023-02-10
• Public Version Status: Update
• Public Device Record Key: 254909b2-e5ab-46cc-ac4d-1c632b6b4a9e
• Distribution End Date: 2023-02-09

Device Description

IV Start 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
33963	Peripheral intravenous catheterization support kit	A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M7521000225	HIBCC	outer box	50	Not in Commercial Distribution	2023-02-09
Primary	M7521000221	HIBCC

Customer Contacts

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