Stradis Medical, LLC.

Basic Information

• Brand Name: Stradis Medical, LLC.
• Primary DI: M7529992814751
• Version / Model: 999281475
• Company Name: STRADIS MEDICAL, LLC
• Labeler DUNS: 174262477
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-17
• Public Version: 2
• Public Version Date: 2023-01-24
• Public Version Status: Update
• Public Device Record Key: 16fe10e9-56d5-40fe-8c65-12612a53b61b
• Distribution End Date: 2023-01-23

Device Description

IVIG Grav Port 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: 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: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
46846	Mechanical infusion pump administration set	A collection of sterile devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication, typically for antibiotic therapy, chemotherapy, or pain management [including patient-controlled analgesia (PCA)] by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It typically consists of a reservoir (e.g., a plastic pouch), plastic tubing, a check valve, a line clamp, and Luer connectors. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M7529992814755	HIBCC	outer box	15	Not in Commercial Distribution	2023-01-23
Primary	M7529992814751	HIBCC

Customer Contacts

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