XTRA

Basic Information

• Brand Name: XTRA
• Primary DI: 08033178113700
• Version / Model: BRB1 BLOOD REINFUSION BAG 1L
• 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: 7a758182-49ef-4a44-885e-fbe6f0548756

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

GMDN Terms

Code	Name	Definition	Implantable	Status
66790	Autotransfusion system blood reinfusion bag	A flexible, plastic pouch intended to collect the blood components (e.g., red or white blood cells, platelets) extracted during an autotransfusion procedure for subsequent transfusion into the patient; it is not intended for blood storage. It may include a short length of 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	18033178113707	GS1	BOX	10	In Commercial Distribution
Primary	08033178113700	GS1
Package	38033178113701	GS1	BOX	50	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K240584	000