CBCII ConstaVac

Basic Information

• Brand Name: CBCII ConstaVac
• Primary DI: 00855168008074
• Version / Model: 225-029-000
• Catalog Number: 225-029-000
• Company Name: 3T MEDICAL SYSTEMS, INC.
• Labeler DUNS: 112462671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-22
• Public Version: 1
• Public Version Date: 2018-11-22
• Public Version Status: New
• Public Device Record Key: 64fedc70-2f8f-4011-b4ca-25cfb8ee9ef6

Device Description

CBCII Collection Only Kit with 1/8” Round PVC Wound Drain

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
47977	Whole-blood-recovery autotransfusion system, powered	An assembly of devices used to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed during and/or after elective and non-elective surgery. It is a complete, closed-circuit system that typically includes a suction set or a catheter for blood access, a collection unit, an autotransfusion bag, safety clamps, non-return valves, various blood screening filters, and a transfusion set. The suction mechanism is typically actuated by a central vacuum system. A trocar may also be included. The device is typically used when there is a lack of donor blood or when compatible blood is not available. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855168008074	GS1
Package	00855168008081	GS1	Pack	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K970714	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3.2 Millimeter

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius