BRAT 2

Basic Information

• Brand Name: BRAT 2
• Primary DI: 08033178106146
• Version / Model: SUCTION ASSEMBLY (Twist Lock)
• Company Name: SORIN GROUP ITALIA SRL
• Labeler DUNS: 442126587
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-06
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b7f986af-2df4-49bb-bf44-6e9557983c8a

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
42924	Blood autotransfusion system tubing	A sterile length of flexible tube, typically made of synthetic polymer material(s), intended to be used in a blood autotransfusion system typically as an extension to channel blood between the bellows and the autotransfusion bag. The tubing may be used to maintain a closed-circuit during blood collection and reinfusion. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	38033178106147	GS1	BOX	12	In Commercial Distribution
Primary	08033178106146	GS1

Premarket Submissions

Submission Number	Supplement Number
K974897	000