ConstaVac CBC II 225-416-000

GUDID 00855168008043

ConstaVac CBCII Conservation Kit with 1/4” Round PVC Wound Drain

3T MEDICAL SYSTEMS, INC.

Whole-blood-recovery autotransfusion system, powered

• Primary Device ID: 00855168008043
• NIH Device Record Key: 2f6a1466-5166-4d0b-ad99-1d610530493c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ConstaVac CBC II
• Version Model Number: 225-416-000
• Catalog Number: 225-416-000
• Company DUNS: 112462671
• Company Name: 3T MEDICAL SYSTEMS, INC.
• 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

Customer Support Contacts

• Phone: 7345259580
• Email: sales@3tmedical.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855168008036 [Primary]
GS1	00855168008043 [Package]; Contains: 00855168008036; Package: Pack [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970714

FDA Product Code

• CAC: Apparatus, Autotransfusion

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: 2019-05-10
• Device Publish Date: 2019-05-02

On-Brand Devices [ConstaVac CBC II]

• 00855168008104: CBCII Blood Conservation Reservoir Only (No Drain)
• 00855168008340: CBCII 1/8" Double Trocar with Quick Disconnect
• 00855168008302: ConstaVac CBCII with Quick Disconnect, 3/16” Round PVC Drain & Trocar
• 00855168008241: ConstaVac CBCII with Quick Disconnect (No Drain)
• 00855168008043: ConstaVac CBCII Conservation Kit with 1/4” Round PVC Wound Drain
• 00855168008166: CBCII Blood Conservation Kit with 3/16” Round PVC Drain & Curved Trocar
• 00855168008067: CBCII Conservation Kit with 3/16” Round PVC Wound Drain
• 00855168008227: ConstaVac CBCII Blood Conservation Kit with 3/16” Round PVC Drain & Double Trocar
• 00855168008142: ConstaVac CBCII Blood Conservation Kit with 1/4” Round PVC Drain & Curved Trocar
• 00855168008128: ConstaVac CBCII Blood Conservation Kit with 1/8” Round PVC Drain & Curved Trocar