Heparin Lock Flush Syringe 1 unit/mL MIH-4422

GUDID 30364253444228

Medefil 1 Unit /mL Heparin Lock Flush Syringe, 2mL fill in 6mL 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 Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, anticoagulant, non-antimicrobial

• Primary Device ID: 30364253444228
• NIH Device Record Key: 942ae73f-a757-494c-9668-9e8b32942156
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heparin Lock Flush Syringe 1 unit/mL
• Version Model Number: 2 mL in 6mL Syringe
• Catalog Number: MIH-4422
• 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	10364253444224 [Unit of Use]
GS1	30364253444228 [Primary]
GS1	50364253444222 [Package]; Package: box [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

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