A.M.G. PMP Sterile US5062

GUDID 08034013782037

EUROSETS SRL

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator

• Primary Device ID: 08034013782037
• NIH Device Record Key: 7ffac85d-32fd-435e-857d-f6dc3a93fba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.M.G. PMP Sterile
• Version Model Number: A.M.G. Module PMP NO T.P. Sterile
• Catalog Number: US5062
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08034013782020 [Primary]
GS1	08034013782037 [Package]; Contains: 08034013782020; Package: [1 Units]; In Commercial Distribution
GS1	08034013782044 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141492

FDA Product Code

• DTZ: Oxygenator, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-22
• Device Publish Date: 2017-02-28

Devices Manufactured by EUROSETS SRL

• 18052705496250 - A.M.G. PP Sterile: 2020-05-19
• 08034013782037 - A.M.G. PMP Sterile: 2020-01-22
• 08034013782037 - A.M.G. PMP Sterile: 2020-01-22