XTRA

Basic Information

• Brand Name: XTRA
• Primary DI: 08033178114141
• Version / Model: COLLECTION SET BX CARDIO 120µm
• Company Name: SORIN GROUP ITALIA SRL
• Labeler DUNS: 442126587
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-20
• Public Version: 1
• Public Version Date: 2024-12-30
• Public Version Status: New
• Public Device Record Key: ed9edd9e-e98b-429d-a849-ace5293d6df7

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAC	Apparatus, autotransfusion	Anesthesiology	868.5830	2
DTN	Reservoir, blood, cardiopulmonary bypass	Cardiovascular	870.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36966	Autotransfusion system blood collection container	A receptacle intended to be used for the collection of autologous blood from a patient in conjunction with a dedicated pump and tubing set (not included) as part of an autotransfusion procedure. It typically includes a lid and short connection tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	38033178114142	GS1	BOX	6	In Commercial Distribution
Primary	08033178114141	GS1

Premarket Submissions

Submission Number	Supplement Number
K241236	000