LIFECATH S 2296.307

GUDID 38498840000190

4 FR LIFECATH S MIDLINE SINGLE WITH INTRODUCER

Vygon Corporation

Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter

• Primary Device ID: 38498840000190
• NIH Device Record Key: c8b477e3-2660-42c0-a3ab-43fcde4f4b74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIFECATH S
• Version Model Number: 2296.307
• Catalog Number: 2296.307
• Company DUNS: 120818216
• Company Name: Vygon Corporation
• Device Count: 1
• DM Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter
• Outer Diameter: 24 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08498840000199 [Primary]
GS1	38498840000190 [Package]; Contains: 08498840000199; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062425

FDA Product Code

• LJS: Catheter,intravascular,therapeutic,long-term greater than 30 days

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: 2021-02-19
• Device Publish Date: 2015-10-08

On-Brand Devices [LIFECATH S]

• 30849884002370: 3 FR LIFECATH S MIDLINE SINGLE
• 30849884002110: 3 FR LIFECATH S MIDLINE SINGLE WITH INTRODUCER
• 38498840008547: 4 FR LIFECATH S MIDLINE SINGLE
• 38498840008530: 3 FR LIFECATH S MIDLINE SINGLE
• 38498840000190: 4 FR LIFECATH S MIDLINE SINGLE WITH INTRODUCER
• 38498840000183: 3 FR LIFECATH S MIDLINE SINGLE WITH INTRODUCER