Premicath 1261.20G

GUDID 30849884002325

PREMICATH 28 G (1 FR) 20 CM CATHETER AND SPLITTING NEEDLE

Vygon Corporation

Peripherally-inserted central venous catheter

• Primary Device ID: 30849884002325
• NIH Device Record Key: d3fb2439-47f5-46e8-8ff8-d530b77118d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premicath
• Version Model Number: 1261.20G
• Catalog Number: 1261.20G
• 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	00849884002324 [Primary]
GS1	30849884002325 [Package]; Contains: 00849884002324; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954302

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: 2020-03-27
• Device Publish Date: 2020-03-19

On-Brand Devices [Premicath]

• 30849884002356: PREMICATH 28 G (1 FR) 30 CM CATHETER WITH STYLET
• 30849884002325: PREMICATH 28 G (1 FR) 20 CM CATHETER AND SPLITTING NEEDLE
• 30849884002318: PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND MICROFLASH INTRODUCER
• 30849884002301: PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND 24 G CANNULA
• 30849884002295: PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND NEOCATH SPLIT
• 30849884001168: PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND SPLITTING NEEDLE
• 38498840009537: PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND NEOCATH SPLIT
• 38498840008523: PREMICATH 28 G (1 FR) 30 CM CATHETER WITH STYLET
• 38498840008516: PREMICATH 28 G (1 FR) 20 CM CATHETER AND SPLITTING NEEDLE
• 38498840008509: PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND MICROFLASH INTRODUCER
• 38498840008493: PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND 24 G CANNULA
• 38498840008486: PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND SPLITTING NEEDLE
• 38498840008479: PREMICATH 28 G (1 FR) 15 CM CATHETER WITH STYLET AND 24 G CANNULA