Heparin Lock Flush Syringe, 10 Unit/mL MIH-2225

GUDID 50364253222257

Medefil Heparin Lock Flush Syringe, 10 Unit/mL, 5mL 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: 50364253222257
• NIH Device Record Key: 0babf579-a3ec-469c-884d-2fbdeb8e7386
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heparin Lock Flush Syringe, 10 Unit/mL
• Version Model Number: 5mL in 6mL Syringe
• Catalog Number: MIH-2225
• 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: 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

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	10364253222259 [Unit of Use]
GS1	30364253222253 [Primary]
GS1	50364253222257 [Package]; Contains: 30364253222253; Package: carton [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: 4
• Public Version Date: 2020-04-20
• Device Publish Date: 2016-12-14

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

• 50364253222523: Medefil Heparin Lock Flush Syringe, 10 Unit/mL, 2.5mL in 6mL Syringe, Does not contain natural r
• 50364253222257: Medefil Heparin Lock Flush Syringe, 10 Unit/mL, 5mL in 6mL Syringe, Does not contain natural rub