Polysite

GUDID 13661234017543

POLYSITE Pressure injectable Implantable Infusion Port with silicone-filled suture holes

PEROUSE MEDICAL

Vascular port/catheter

• Primary Device ID: 13661234017543
• NIH Device Record Key: 6e059b1a-f9b8-4c58-9c28-8eceac36fb93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polysite
• Version Model Number: 2016SPI
• Company DUNS: 267476323
• Company Name: PEROUSE MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661234017546 [Primary]
GS1	13661234017543 [Package]; Contains: 03661234017546; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122834

FDA Product Code

• LJT: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-03-15

On-Brand Devices [Polysite]

• 13661234011633: POLYSITE Implantable Infusion Port
• 13661234011626: POLYSITE Implantable Infusion Port with silicone-filled suture holes
• 13661234011619: POLYSITE Pressure injectable Implantable Infusion Port
• 13661234011602: POLYSITE Pressure injectable Implantable Infusion Port with silicone-filled suture holes
• 13661234011596: POLYSITE Implantable Infusion Port
• 13661234011589: POLYSITE Implantable Infusion Port with silicone-filled suture holes
• 13661234011572: Polysite Pressure Injectable Implantable Infusion Port
• 13661234011565: POLYSITE Pressure injectable Implantable Infusion Port with silicone-filled suture holes
• 13661234011558: POLYSITE Implantable Infusion Port
• 13661234011541: POLYSITE Implantable Infusion Port with silicone-filled suture holes
• 13661234011534: POLYSITE Pressure injectable Implantable Infusion Port
• 13661234011527: POLYSITE Pressure injectable Implantable Infusion Port with silicone-filled suture holes
• 13661234017659: POLYSITE Implantable Infusion Port
• 03661234017645: POLYSITE Implantable Infusion Port with silicone-filled suture holes
• 13661234017635: POLYSITE Pressure injectable Implantable Infusion Port
• 13661234017628: POLYSITE Pressure injectable Implantable Infusion Port with silicone-filled suture holes
• 13661234017611: POLYSITE Implantable Infusion Port
• 13661234017604: POLYSITE Implantable Infusion Port with silicone-filled suture holes
• 13661234017598: Polysite Pressure Injectable Implantable Infusion Port
• 13661234017581: POLYSITE Pressure injectable Implantable Infusion Port with silicone-filled suture holes
• 13661234017574: POLYSITE Implantable Infusion Port
• 13661234017567: POLYSITE Implantable Infusion Port with silicone-filled suture holes
• 13661234017550: POLYSITE Pressure injectable Implantable Infusion Port
• 13661234017543: POLYSITE Pressure injectable Implantable Infusion Port with silicone-filled suture holes