Syringe, 10 mL

Basic Information

• Brand Name: Syringe, 10 mL
• Primary DI: 16286780610023
• Version / Model: E01P3
• Catalog Number: E01P3
• Company Name: Front Line Medical Technologies Inc.
• Labeler DUNS: 242512799
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-09
• Public Version: 1
• Public Version Date: 2022-02-17
• Public Version Status: New
• Public Device Record Key: 4d2e4516-796e-435e-9a7f-10a53ece5bfa

Device Description

The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon. The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

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: No
• 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
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	870.4450	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
Primary	16286780610023	GS1

Premarket Submissions

Submission Number	Supplement Number
K201652	000

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Milliliter