Stradis Medical, LLC

Basic Information

• Brand Name: Stradis Medical, LLC
• Primary DI: M752HCT105002
• Version / Model: HCT10500
• Company Name: STRADIS MEDICAL LLC
• Labeler DUNS: 043537671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-07-07
• Public Version: 1
• Public Version Date: 2020-07-15
• Public Version Status: New
• Public Device Record Key: 66e915fd-0bd0-4e0b-bb1a-705fc26c864a

Device Description

500mL EVA Bags, 2 Port

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
KPE	Container, I.V.	General Hospital	880.5025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35127	Intravenous administration bag/bottle	An empty pouch or bottle made of plastic or glass intended to contain a fluid (e.g., saline, medication) for intravenous (IV) administration; some types may in addition be intended for enteral feeding applications. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an IV administration set] and is not intended to be directly connected to the IV catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M752HCT105006	HIBCC	outer box	7	In Commercial Distribution
Primary	M752HCT105002	HIBCC
Unit of Use	M752HCT105000	HIBCC

Customer Contacts

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