Ambulating Bulb 225-028-852

GUDID 00855168008579

Ambulating Bulb

3T MEDICAL SYSTEMS, INC.

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 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: 00855168008579
• NIH Device Record Key: 5c6b6603-3c53-4f57-97f4-96dbc4fe2886
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambulating Bulb
• Version Model Number: 225-028-852
• Catalog Number: 225-028-852
• 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: true
• 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
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com
• Phone: 7345259580
• Email: sales@3tmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855168008579 [Primary]
GS1	00855168008586 [Package]; Package: Pack [10 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: 2021-04-12
• Device Publish Date: 2021-04-02

Devices Manufactured by 3T MEDICAL SYSTEMS, INC.

• 00855168008579 - Ambulating Bulb: 2021-04-12Ambulating Bulb
• 00855168008579 - Ambulating Bulb: 2021-04-12 Ambulating Bulb
• 00855168008067 - Constavac CBC II: 2019-11-18 CBCII Conservation Kit with 3/16” Round PVC Wound Drain
• 00855168008227 - Constavac CBC II: 2019-10-16 ConstaVac CBCII Blood Conservation Kit with 3/16” Round PVC Drain & Double Trocar
• 00855168008128 - Constavac CBC II: 2019-08-28 ConstaVac CBCII Blood Conservation Kit with 1/8” Round PVC Drain & Curved Trocar
• 00855168008142 - Constavac CBC II: 2019-08-15 ConstaVac CBCII Blood Conservation Kit with 1/4” Round PVC Drain & Curved Trocar
• 00855168008630 - Constavac CBC III: 2019-07-16 ConstaVac CBCIII Conservation Kit with 3.2 mm Round PVC Wound Drain
• 00855168008654 - Constavac CBC III: 2019-07-16 ConstaVac CBCIII Blood Conservation Kit with 4.8 mm Round PVC Wound Drain
• 00855168008166 - Constavac CBC II: 2019-05-31 CBCII Blood Conservation Kit with 3/16” Round PVC Drain & Curved Trocar