XTRA

GUDID 38033178114326

SORIN GROUP ITALIA SRL

Autotransfusion system aspiration/anticoagulation tubing set

• Primary Device ID: 38033178114326
• NIH Device Record Key: 064314c9-76ca-4506-9530-e315654d6b3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XTRA
• Version Model Number: 1/4 AND 3/8-INCH AAL
• 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	08033178114325 [Primary]
GS1	38033178114326 [Package]; Contains: 08033178114325; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241236

FDA Product Code

• DTN: Reservoir, blood, cardiopulmonary bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-30
• Device Publish Date: 2024-12-20

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
• 38033178114739: 1/4-20 ft AAL
• 38033178114333: SEQUESTRATION SET X
• 38033178114326: 1/4 AND 3/8-INCH AAL
• 38033178114142: COLLECTION SET BX CARDIO 120µm
• 38033178114135: XRES T BLOOD COLL RESERVOIR W CARDIO
• 38033178114128: COLLECTION SET TX CARDIO
• 38033178114111: PROCEDURE SET BX/225
• 38033178114104: PROCEDURE SET BX/175
• 38033178114098: PROCEDURE SET BX/125
• 38033178114081: PROCEDURE SET BX/55
• 38033178114074: COLLECTION SET TX
• 38033178114067: XRES T BLOOD COLLECTION RESERVOIR
• 38033178114050: PROCEDURE SET TX/225
• 38033178114043: PROCEDURE SET TX/175
• 38033178114036: PROCEDURE SET TX/125
• 38033178114029: PROCEDURE SET TX/55
• 38033178114012: PROCED.SET BX 225 - 120µm
• 38033178114005: COLLECTION SET BX 120µm
• 38033178113992: XRES B BLOOD COLL RESERV 120µm
• 38033178113985: WASTE BAG X 10 L
• 38033178113978: XRES B RESERVOIR "Y" ADAPTOR
• 38033178113961: COLLECTION SET BX
• 38033178113954: BOWL SET X/175
• 38033178113947: BOWL SET X/125