MEDRAD® PRES PRES50

GUDID 10616258005413

CT Pressure Rated Extension Set - 50 (CT - EXTENSION SET,QWIKSTRIPS, BOX OF 50) (83920742)

BAYER MEDICAL CARE INC.

Intravenous administration tubing extension set Intravenous administration tubing extension set

• Primary Device ID: 10616258005413
• NIH Device Record Key: 34c68f30-de78-45fd-98cc-cee8f88eeb3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® PRES
• Version Model Number: PRES50
• Catalog Number: PRES50
• 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	00616258005416 [Primary]
GS1	10616258005413 [Package]; Contains: 00616258005416; Package: [50 Units]; In Commercial Distribution

FDA Product Code

• KGZ: Accessories, Catheter

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: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [MEDRAD® PRES]

• 10616258005413: CT Pressure Rated Extension Set - 50 (CT - EXTENSION SET,QWIKSTRIPS, BOX OF 50) (83920742)
• 40616258022633: ASSY, TBG, PRES 50, MC (86990679)