XTRA

GUDID 38033178110809

SORIN GROUP ITALIA SRL

Red blood cell-recovery autotransfusion system

• Primary Device ID: 38033178110809
• NIH Device Record Key: 2573166d-8632-4d3a-8836-4d993ce93a56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XTRA
• Version Model Number: PROCEDURE SET BX/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	08033178110808 [Primary]
GS1	38033178110809 [Package]; Contains: 08033178110808; Package: BOX [3 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