Waste bag 10 l 9006284

GUDID 04052682000522

Waste bag, 10 Liter, is a replacement waste bag to be used with the AT1 Autotransfusion set.

Fresenius Kabi AG

Blood-processing autotransfusion system set

• Primary Device ID: 04052682000522
• NIH Device Record Key: d1162379-8dda-4866-81c8-92627ed1b5cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Waste bag 10 l
• Version Model Number: 9006284
• Catalog Number: 9006284
• 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	04052682000522 [Primary]
GS1	04052682000539 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	04052682000546 [Package]; Contains: 04052682000539; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK880007

FDA Product Code

• GKT: Separator, Automated, Blood Cell, Diagnostic

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: 2015-11-10

Devices Manufactured by Fresenius Kabi AG

• 10810020441380 - Plasmalink Bottle 1000 mL with locking luer adapter: 2025-01-23 For the collection of blood components. Sterile Fluid Path
• 10810020440512 - Adaptive Nomogram Transfer Pack: 2024-12-20 For processing and/or storage of blood and blood components. Sterile Fluid Path
• 00811505030450 - Ivenix Infusion System: 2024-12-16 Infusion Management System (IMS)
• 00811505030467 - Ivenix Infusion System: 2024-12-16 Large Volume Pump (LVP) Software (order 1 per pump)
• 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