Stradis Medical, LLC.

Basic Information

• Brand Name: Stradis Medical, LLC.
• Primary DI: M7521000161
• Version / Model: 100016
• 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: 2
• Public Version Date: 2023-02-10
• Public Version Status: Update
• Public Device Record Key: 43e2fd8b-1ce9-4997-bf23-b67d7f4dd838
• Distribution End Date: 2023-02-09

Device Description

Pump Supply Kit C

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
62713	Mechanical infusion pump kit, medicated	A collection of sterile devices intended to be used in a clinical setting for continuous localized infusion of a single dose of analgesic medication (e.g., ropivacaine), using a non-electric/non-elastic mechanical infusion pump, for regional anaesthesia and postoperative pain management. It consists of a mechanical infusion pump prefilled with medication, and additional medication administration devices (e.g., infusion catheter). The infusion catheter is intended to be inserted during surgery and connected to the tubing line of the prefilled infusion pump for infusion of the drug into the operative site. The device can be worn by the patient during ambulation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7521000161	HIBCC
Package	M7521000165	HIBCC	outer box	24	Not in Commercial Distribution	2023-02-09

Customer Contacts

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