XTRA

GUDID 38033178110045

SORIN GROUP ITALIA SRL

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: 38033178110045
• NIH Device Record Key: 185bcd10-476f-45e3-b743-c426fa076eeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XTRA
• Version Model Number: BOWL SET X/225
• Company DUNS: 442126587
• Company Name: SORIN GROUP ITALIA 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	08033178110044 [Primary]
GS1	38033178110045 [Package]; Contains: 08033178110044; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101586

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: 2021-01-08
• Device Publish Date: 2015-07-06

On-Brand Devices [XTRA]

• 38033178112469: PROCEDURE SET BX/225 - 120 µm
• 38033178112452: COLLECTION SET CARDIO BX-120 µm
• 38033178112445: COLLECTION SET BX-120 µm
• 38033178112438: XRES B BLOOD COLL.RESERVOIR - 120 µm
• 38033178111851: XRES T BLOOD COLL.RESERVOIR W.CARDIO KIT
• 38033178110830: WB 10 WASTE BAG X 10Lt
• 38033178110823: BRB 1 BLOOD REINFUSION BAG X 1Lt
• 38033178110809: PROCEDURE SET BX/225
• 38033178110793: PROCEDURE SET BX/175
• 38033178110786: PROCEDURE SET BX/125
• 38033178110779: PROCEDURE SET BX/55
• 38033178110762: COLLECTION SET CARDIO BX
• 38033178110755: COLLECTION SET BX
• 38033178110748: XRES B BLOOD COLLECTION RESERVOIR
• 38033178110533: COLLECTION SET CARDIO TX
• 38033178110526: SEQUESTRATION SET X
• 38033178110410: COLLECTION SET TX
• 38033178110144: XRES T BLOOD COLLECTION RESERVOIR
• 38033178110083: PROCEDURE SET TX/225
• 38033178110076: PROCEDURE SET TX/175
• 38033178110069: PROCEDURE SET TX/125
• 38033178110052: PROCEDURE SET TX/55
• 38033178110045: BOWL SET X/225
• 38033178110038: BOWL SET X/175
• 38033178110021: BOWL SET X/125
• 38033178110014: BOWL SET X/55