A.M.G.PMP PEDIATRIC US5087

GUDID 18052705493358

EUROSETS SRL

Extracorporeal membrane oxygenator

• Primary Device ID: 18052705493358
• NIH Device Record Key: 43f21e1d-8954-456d-9e30-e6229a08d089
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.M.G.PMP PEDIATRIC
• Version Model Number: A.M.G.PMP PEDIATRIC STERILE
• Catalog Number: US5087
• Company DUNS: 439962374
• Company Name: EUROSETS SRL
• 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	08052705493351 [Primary]
GS1	18052705493358 [Package]; Contains: 08052705493351; Package: [1 Units]; In Commercial Distribution
GS1	28052705493355 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202206

FDA Product Code

• DTZ: Oxygenator, Cardiopulmonary Bypass

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: 2025-02-27
• Device Publish Date: 2025-02-19

Devices Manufactured by EUROSETS SRL

• 08034013785489 - HOLDER: 2025-02-27
• 18052705493358 - A.M.G.PMP PEDIATRIC: 2025-02-27
• 18052705493358 - A.M.G.PMP PEDIATRIC: 2025-02-27
• 18052705493365 - AMG PMP INFANT STERILE: 2025-02-27
• 18052705496250 - A.M.G. PP Sterile: 2020-05-19
• 08034013782037 - A.M.G. PMP Sterile: 2020-01-22