Heparin Lock Flush Syringe 10 Units/mL MIH-2235

GUDID 70364253222350

Medefil Heparin Lock Flush Syringe 10 Units/mL, 5mL fill in 12mL syringe, Does not contain natural rubber latex or preservatives, Contents and its pathway are sterile, Single Use

MEDEFIL, INC.

Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial

• Primary Device ID: 70364253222350
• NIH Device Record Key: 3fe395e6-d9b1-4830-afbd-ade7fdf8711e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heparin Lock Flush Syringe 10 Units/mL
• Version Model Number: 5mL in 12mL syringe
• Catalog Number: MIH-2235
• 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
• Phone: 630-682-4600
• Email: pradeep@medefilinc.com
• Phone: 630-682-4600
• Email: pradeep@medefilinc.com
• Phone: 630-682-4600
• Email: pradeep@medefilinc.com
• Phone: 630-682-4600
• Email: pradeep@medefilinc.com
• Phone: 630-682-4600
• Email: pradeep@medefilinc.com
• Phone: 630-682-4600
• Email: pradeep@medefilinc.com
• Phone: 630-682-4600
• Email: pradeep@medefilinc.com
• 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
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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	10364253222358 [Unit of Use]
GS1	30364253222352 [Primary]
GS1	50364253222356 [Package]; Contains: 30364253222352; Package: carton [16 Units]; In Commercial Distribution
GS1	70364253222350 [Package]; Contains: 50364253222356; Package: pallet [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092491

FDA Product Code

• NZW: Heparin, 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: 5
• Public Version Date: 2020-04-20
• Device Publish Date: 2016-04-21

On-Brand Devices [Heparin Lock Flush Syringe 10 Units/mL ]

• 70364253222350: Medefil Heparin Lock Flush Syringe 10 Units/mL, 5mL fill in 12mL syringe, Does not contain natur
• 30364253222338: Medefil Heparin Lock Flush Syringe 10 Uniits/mL, 3 mL fill in 12 mL syringe, Does not contain n
• 30364253222239: Medefil Heparin Lock Flush Syringe, 10 Units/mL, 3mL fill in 6mL syringe, Does not contain natur
• 30364253222215: Medefil 10 Units/mL Heparin Lock Flush Syringe, 1 mL fill in 6 mL syringe, Does not contain natu