Synergy

Basic Information

• Brand Name: Synergy
• Primary DI: 00876604001190
• Version / Model: KIT-405-51
• Company Name: Health Line International Corporation
• Labeler DUNS: 806251398
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-11
• Public Version: 5
• Public Version Date: 2023-05-24
• Public Version Status: Update
• Public Device Record Key: 95709a3e-003e-4f7b-b170-114a32282166

Device Description

5FR X 60cm Single Lumen Synergy CT PICC IR 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LJS	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days	General Hospital	880.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36257	Peripherally-inserted central venous catheter	A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20876604001194	GS1	Carton	4	In Commercial Distribution
Package	10876604001197	GS1	Inner	5	In Commercial Distribution
Primary	00876604001190	GS1

Premarket Submissions

Submission Number	Supplement Number
K101329	000