Constavac CBC III 225-426-000W

GUDID 00855168008654

ConstaVac CBCIII Blood Conservation Kit with 4.8 mm Round PVC Wound Drain

3T MEDICAL SYSTEMS, INC.

Whole-blood-recovery autotransfusion system, powered

• Primary Device ID: 00855168008654
• NIH Device Record Key: 79c97f44-6b70-4e34-a1a4-309a79d0f37c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Constavac CBC III
• Version Model Number: 225-426-000W
• Catalog Number: 225-426-000W
• 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
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855168008654 [Package]; Contains: 00855168008661; Package: Pack [6 Units]; In Commercial Distribution
GS1	00855168008661 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-16
• Device Publish Date: 2019-03-01

On-Brand Devices [Constavac CBC III]

• 00855168008654: ConstaVac CBCIII Blood Conservation Kit with 4.8 mm Round PVC Wound Drain
• 00855168008630: ConstaVac CBCIII Conservation Kit with 3.2 mm Round PVC Wound Drain