10” (25 cm) High Pressure Connector Tube DCT 100

GUDID 40616258008538

10" High Pressure Connector Tube with fixed hub (TUBING, 10" CONNECTOR #82011102, MC) (85029037)

BAYER MEDICAL CARE INC.

Radiographic procedure tubing Radiographic procedure tubing

• Primary Device ID: 40616258008538
• NIH Device Record Key: ab9cbcea-1720-4827-a434-435e28c18592
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 10” (25 cm) High Pressure Connector Tube
• Version Model Number: DCT 100
• Catalog Number: DCT 100
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258008530 [Primary]
GS1	20616258008534 [Package]; Contains: 00616258008530; Package: [25 Units]; In Commercial Distribution
GS1	40616258008538 [Package]; Contains: 20616258008534; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810924

FDA Product Code

• DWE: Tubing, Pump, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-05

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