ATF 40 Fast Start Kit 9108494

GUDID 04052682000683

ATF 40 Fast Start Kit is a kit consisting of AT1, ATR 40 Autotransfusion reservoir and the ATS Suction Line.

Fresenius Kabi AG

Blood-processing autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set

• Primary Device ID: 04052682000683
• NIH Device Record Key: 4d9adaf4-5b61-419a-b544-58f352a5e5fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATF 40 Fast Start Kit
• Version Model Number: 9108494
• Catalog Number: 9108494
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052682000676 [Primary]
GS1	04052682000683 [Package]; Contains: 04052682000676; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960006

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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