Medefil Heparin Lock Flush Syringe, 10 Unit/mL

Basic Information

• Brand Name: Medefil Heparin Lock Flush Syringe, 10 Unit/mL
• Primary DI: 30364253222222
• Version / Model: 2mL in 6mL Syringe
• Catalog Number: MIH-2222
• Company Name: MEDEFIL, INC.
• Labeler DUNS: 016448669
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2016-12-14
• Public Version: 5
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: 9b92002a-cbf5-443f-9f84-9eccfd51bf16

Device Description

Medefil Heparin Lock Flush Syringe, 10 Unit/mL, 2mL in 6mL Syringe, Does not contain natural rubber latex or preservatives. Contents and its pathway are sterile. Single use.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• 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
NZW	Heparin, Vascular Access Flush	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47132	Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial	A solution which contains a low dose (e.g., 10 i.u. ) of an anticoagulant agent(s) [typically heparin] intended to flush the lumen of an in situ intravenous access device (IVAD), typically a peripheral intravenous cannula or central venous catheter, to maintain patency; it does not include an antimicrobial agent. Also known as lock solution, the device is available in a small container (e.g., bottle) or prefilled syringe. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50364253222226	GS1	carton	16	In Commercial Distribution
Primary	30364253222222	GS1
Unit of Use	10364253222228	GS1

Premarket Submissions

Submission Number	Supplement Number
K092491	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius