ATY Y-Adapter 9108404

GUDID 04052682000577

ATY Y-Adapter is a Y-Adapter to connect two Autotransfusion reservoirs with ¼” female outlet connector to an Autotransfusion device.

Fresenius Kabi AG

Blood-processing autotransfusion system set

• Primary Device ID: 04052682000577
• NIH Device Record Key: e5db9699-f2b5-47a7-a66a-22b1083ea911
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATY Y-Adapter
• Version Model Number: 9108404
• Catalog Number: 9108404
• Company DUNS: 315654579
• Company Name: Fresenius Kabi AG
• 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: true
• 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

Customer Support Contacts

• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com
• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052682000553 [Primary]
GS1	04052682000560 [Package]; Contains: 04052682000553; Package: [8 Units]; In Commercial Distribution
GS1	04052682000577 [Package]; Contains: 04052682000560; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984233

FDA Product Code

• CAC: Apparatus, Autotransfusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-03
• Device Publish Date: 2015-09-01

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• 14086000100059 - AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector: 2024-11-07 For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Sol
• 04086000860888 - COMPOGUARD Advance Basic: 2024-11-07 Device, Blood Mixing and Weighing
• 04086000860895 - COMPOGUARD Advance Data: 2024-11-06 Device, Blood Mixing and Weighing
• 04086000860901 - COMPOGUARD Advance COMPLETE: 2024-11-06 Device, Blood Mixing and Weighing
• 00810020440591 - AMICUS Separator Legacy Software: 2024-04-04 Software version for AMICUS Separator Legacy Device