CellTrans

GUDID 25060238201135

CellTrans Postoperative Autotransfusion System with two 1/8” needle & drains

SUMMIT MEDICAL LIMITED

Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual Whole-blood-recovery autotransfusion system, manual

• Primary Device ID: 25060238201135
• NIH Device Record Key: 69b70de9-63ea-4afe-95ba-7390134d68db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CellTrans
• Version Model Number: ABT4510
• Company DUNS: 221751311
• Company Name: SUMMIT MEDICAL LIMITED
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401451821311
• Email: customer.service@summit-medica
• Phone: +4401451821311
• Email: customer.service@summit-medica
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk
• Phone: +4401451821311
• Email: customer.service@summit-medical.co.uk

Device Dimensions

• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060238201138 [Primary]
GS1	25060238201135 [Package]; Contains: 15060238201138; Package: Box [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022489

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: 2019-01-21
• Device Publish Date: 2018-12-21

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