PEROUSE MEDICAL VPE2015SPI

GUDID 13661234027450

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

PEROUSE MEDICAL

Vascular port/catheter

• Primary Device ID: 13661234027450
• NIH Device Record Key: a8c75a08-4ef9-47f8-9f55-6535c9dcdd83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEROUSE MEDICAL
• Version Model Number: 2015SPI
• Catalog Number: VPE2015SPI
• Company DUNS: 267476323
• Company Name: PEROUSE MEDICAL
• 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	03661234027453 [Primary]
GS1	13661234027450 [Package]; Contains: 03661234027453; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-30
• Device Publish Date: 2026-01-22

On-Brand Devices [PEROUSE MEDICAL]

• 33661234025269: NEEDLE GUIDE Ø2,25MM
• 33661234025252: NEEDLE GUIDE Ø1,2MM
• 33661234025245: NEEDLE GUIDE Ø1,0MM
• 43661234025228: NEEDLE GUIDE Ø1,8MM
• 33661234025184: NEEDLE GUIDE Ø0,9MM
• 43661234025235: NEEDLE GUIDE Ø0,9MM
• 43661234025198: NEEDLE GUIDE Ø1,0MM
• 33661234025207: NEEDLE GUIDE Ø1,2MM
• 33661234025214: NEEDLE GUIDE Ø1,4MM
• 13661234027481: POLYSITE ®Pressure injectable Implantable Infusion Port with silicone-filled suture holes
• 13661234027474: POLYSITE ®Pressure injectable Implantable Infusion Port with silicone-filled suture holes
• 13661234027467: POLYSITE ®Pressure injectable Implantable Infusion Port with silicone-filled suture holes
• 13661234027450: POLYSITE ®Pressure injectable Implantable Infusion Port with silicone-filled suture holes