Syringe Kit - Stroke

Basic Information

• Brand Name: Syringe Kit - Stroke
• Primary DI: 00816777025906
• Version / Model: MVSK60
• Catalog Number: MVSK60
• Company Name: MICROVENTION INC.
• Labeler DUNS: 003263105
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2021-11-26
• Public Version: 1
• Public Version Date: 2021-12-06
• Public Version Status: New
• Public Device Record Key: 68a13274-2119-455d-8e1e-9402ba944f61

Device Description

Syringe Kit - Stroke

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FMF	Syringe, piston	General Hospital	880.5860	2
BYY	TUBE, ASPIRATING, FLEXIBLE, CONNECTING	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47017	General-purpose syringe, single-use	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	30816777026706	GS1
Primary	00816777025906	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K994253	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			60 mL