VYGON 1261.203A

GUDID 38498840011141

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

Vygon Corporation

Peripherally-inserted central venous catheter

• Primary Device ID: 38498840011141
• NIH Device Record Key: 74ace936-9faa-4b34-951f-678f5de936e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VYGON
• Version Model Number: 1261.203A
• Catalog Number: 1261.203A
• 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	08498840011140 [Primary]
GS1	38498840011141 [Package]; Contains: 08498840011140; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041468

FDA Product Code

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

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-19
• Device Publish Date: 2017-11-21

On-Brand Devices [VYGON]

• 38498840011929: MARKED NITI/AU GUIDEWIRE, 0/018" X 130CM
• 38498840011905: MARKED NITINOL GUIDEWIRE, 0.018" X 80CM
• 38498840012216: 3.5F X 5CM PTFE TEARAWAY INTRODUCER
• 38498840011912: STAINLESS STEEL GUIDEWIRE, 0.018" X 80CM
• 38498840011899: NITI/AU GUIDEWIRE, 0.018" X 70CM
• 38498840011882: NITI/SS GUIDEWIRE, 0.018" X 45CM
• 38498840011875: MARKED NITI/AU GUIDEWIRE, 0.018" X 45CM
• 38498840011813: 5.5F X 10CM PTFE TEARAWAY INTRODUCER
• 38498840011806: 4.5F X 10CM PTFE TEARAWAY INTRODUCER
• 38498840011790: 6F X 7CM PTFE TEARAWAY INTRODUCER
• 38498840011783: 5.5F X 7CM PTFE TEARAWAY INTRODUCER
• 38498840011776: 4.0F X 7CM PTFE TEARAWAY INTRODUCER
• 38498840011769: 21GA. X 7CM INTRODUCER NEEDLE
• 38498840011752: 21GA. X 4CM INTRODUCER NEEDLE
• 38498840011318: 21GA SAFETY NEEDLE, 7CM
• 38498840011301: 21GA SAFETY NEEDLE, 4CM
• 38498840012568: ULTRASOUND IV START KIT
• 38498840012230: 4" MICROBORE EXTENSION SET
• 38498840012223: 3.5FR MST INSERTION KIT
• 38498840012193: CENTRAL LINE DRESSING KIT
• 38498840011844: 6.0FR MST INSERTION KIT
• 38498840011837: 5.5FR MST INSERTION KIT
• 38498840011820: 4.0FR MST INSERTION KIT
• 38498840012537: PREP KIT
• 38498840012391: PROCEDURE KIT
• 38498840012384: PICC INSERTION TRAY
• 38498840012360: VAD KIT W/ CHLORAPREP
• 38498840012353: VAD ACCESS KIT
• 38498840012308: VAD ACCESS KIT
• 38498840012278: VAD ACCESS TRAY
• 38498840012254: LEADERFLEX INSERTION KIT
• 38498840011936: PREP KIT
• 38498840011677: PROCEDURE TRAY
• 38498840011646: PIV INSERTION KIT
• 38498840011363: CENTRAL LINE KIT
• 38498840011226: CENTRAL VENOUS CATHETER KIT
• 38498840011042: PICC INSERTION TRAY
• 38498840011035: LEADERFLEX INSERTION KIT
• 38498840010830: LEADERFLEX INSERTION KIT
• 38498840010663: CENTRAL LINE KIT
• 38498840010649: PICC INSERTION TRAY
• 38498840010632: PICC INSERTION TRAY
• 38498840010564: NEONATAL PICC TRAY
• 38498840010502: CENTRAL LINE KIT
• 38498840010496: PICC/MIDLINE KIT
• 38498840010151: LEADERFLEX INSERTION TRAY
• 38498840010144: PICC LINE TRAY
• 38498840010076: INSERTION TRAY
• 38498840010069: MAXIMUM BARRIER TRAY
• 38498840010007: PICC INSERTION TRAY