VYGON SS-885-2

GUDID 38498840012728

4" MICROBORE BIFURCATED EXTENSION SET

Vygon Corporation

Intravenous administration tubing extension set

• Primary Device ID: 38498840012728
• NIH Device Record Key: 0923b02a-457b-4e3c-a714-d8fe856097a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VYGON
• Version Model Number: SS-885-2
• Catalog Number: SS-885-2
• Company DUNS: 120818216
• Company Name: Vygon Corporation
• Device Count: 1
• DM Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08498840012727 [Primary]
GS1	38498840012728 [Package]; Contains: 08498840012727; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101368

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-30
• Device Publish Date: 2019-09-20

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