Normal Saline IV Flush Syriinge MIS-1152

GUDID 50364253111520

Medefil Normal Saline IV Flush Syringe , 2.5mL fill 6mL Syringe, Does not contain natural rubber latex, Contents and its pathway are sterile, Single U

MEDEFIL, INC.

Vascular catheter flush syringe

• Primary Device ID: 50364253111520
• NIH Device Record Key: e9df5db3-cc2d-491c-bc26-13dc20c0b124
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Normal Saline IV Flush Syriinge
• Version Model Number: 2.5mL in 6mL syringe
• Catalog Number: MIS-1152
• Company DUNS: 016448669
• Company Name: MEDEFIL, INC.
• Device Count: 60
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 630-682-4600
• Email: pradeep@medefilinc.com
• Phone: 630-682-4600
• Email: pradeep@medefilinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10364253111522 [Unit of Use]
GS1	30364253111526 [Primary]
GS1	50364253111520 [Package]; Contains: 30364253111526; Package: carton [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091583

FDA Product Code

• NGT: Saline, Vascular Access Flush

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-09

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