VYGON 1212.04

GUDID 33660812011298

Leaderflex 22G (0,7mm x 40mm) 22G

VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG

Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter

• Primary Device ID: 33660812011298
• NIH Device Record Key: 6c078985-daf9-47de-a2d5-aa4e5740cdbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VYGON
• Version Model Number: 1212.04
• Catalog Number: 1212.04
• Company DUNS: 315994731
• Company Name: VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03660812011297 [Primary]
GS1	33660812011298 [Package]; Contains: 03660812011297; Package: Box [20 Units]; In Commercial Distribution
GS1	53660812011292 [Package]; Package: Case [1 Units]; In Commercial Distribution

FDA Product Code

• FOZ: Catheter,intravascular,therapeutic,short-term less 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: 3
• Public Version Date: 2021-02-19
• Device Publish Date: 2018-03-30

On-Brand Devices [VYGON]

• 33660812082236: Nutriline
• 33660812075382: EPICUTANEO PUR
• 33660812039230: Leaderflex 22G (0,7mm x 60mm) 22G
• 33660812011311: Leaderflex 22G 0,5x0,7mmx200mm
• 33660812011304: Leaderflex 22G (0,7mm x 80mm) 22G
• 33660812011298: Leaderflex 22G (0,7mm x 40mm) 22G
• 33660812124493: Extension set for ECC
• 53660812138715: premicath Ø0.35mmx200mm 28G 1Fr - Catheter with stylet and splitting needle
• 53660812125470: leaderflex 0.55mmx0.75mmx200mm 22G - 1 lumen catheter set
• 53660812125432: leaderflex 0.55mmx0.75mmx80mm 22G - 1 lumen catheter set
• 53660812125401: leaderflex 0.55mmx0.75mmx60mm 22G - 1 lumen catheter set
• 33660812151604: epicutaneo cava - Catheter with winged needle (0,3x0,6mmx150mm) 24G (2Fr)
• 53660812151592: epicutaneo cava - Catheter with winged needle (0,3x0,6mmx500mm) 24G (2Fr)
• 03660812125390: Leaderflex 22G (0,7mm x 40mm)