Normal Saline IV Flush Syringe MIS-1135

GUDID 30364253111359

Medefil Normal Saline IV Flush Syringe, 5mL fill in 12mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are

MEDEFIL, INC.

Vascular catheter flush syringe

• Primary Device ID: 30364253111359
• NIH Device Record Key: e3e01341-5a18-4942-8e69-d69f5ca3983d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Normal Saline IV Flush Syringe
• Version Model Number: 5mL in 12mL syringe
• Catalog Number: MIS-1135
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10364253111355 [Unit of Use]
GS1	30364253111359 [Primary]
GS1	50364253111353 [Package]; Package: box [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: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-04-21

On-Brand Devices [Normal Saline IV Flush Syringe]

• 30364253111359: Medefil Normal Saline IV Flush Syringe, 5mL fill in 12mL syringe, Does not contain natural rubbe
• 30364253111335: Medefil Normal Saline IV Flush Syringe, 3mL fill in 12mL syringe, Does not contain natural rubbe
• 30364253111304: Medefil Normal Saline IV Flush Syringe, 10mL fill in 12mL syringe, Does not contain natural rubb
• 30364253111250: Medefil Normal Saline IV Flush Syringe, 5mL fill in 6mL syringe, Does not contain natural rubber
• 30364253111236: Medefil Normal Saline IV Flush Syringe, 3mL fill in 6mL syringe, Does not contain natural rubber
• 50364253111223: Medefil Normal Saline IV Flush Syringe, 2mL in 6mL Syringe, Does not contain natural rubber late