Nutriline Twinflo 1252.232M

GUDID 30849884002257

NUTRLINE TWINFLOW 24 G (2FR) 30 CM DUAL LUMEN CATHETER AND MICROFLASH 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 Peripherally-inserted central venous catheter

• Primary Device ID: 30849884002257
• NIH Device Record Key: c6ab52a5-9502-4af4-a9dc-3c2ed4fc0f7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nutriline Twinflo
• Version Model Number: 1252.232M
• Catalog Number: 1252.232M
• 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
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849884002256 [Primary]
GS1	30849884002257 [Package]; Contains: 00849884002256; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052475

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-23
• Device Publish Date: 2020-03-13

On-Brand Devices [Nutriline Twinflo]

• 30849884002257: NUTRLINE TWINFLOW 24 G (2FR) 30 CM DUAL LUMEN CATHETER AND MICROFLASH INTRODUCER
• 30849884000840: NUTRLINE TWINFLOW 24 G (2FR) 30 CM DUAL LUMEN CATHETER
• 30849884000833: NUTRLINE TWINFLOW 24 G (2FR) 30 CM DUAL LUMEN CATHETER WITH STYLET AND MICROFLASH INTRODUCER
• 38498840009452: NUTRLINE TWINFLOW 24 G (2FR) 30 CM DUAL LUMEN CATHETER
• 38498840009445: NUTRLINE TWINFLOW 24 G (2FR) 30 CM DUAL LUMEN CATHETER WITH STYLET AND MICROFLASH INTRODUCER
• 38498840000138: NUTRLINE TWINFLOW 24 G (2FR) 30 CM DUAL LUMEN CATHETER AND MICROFLASH INTRODUCER