Quick Fill Disposable Syringe Fill Tube QFT 200

GUDID 10616258007837

Individually Packaged Quick Fill Tubes (PKG,TUBE,QUICK FILL,QFT 200,RAD,MC,CH) (60729296)

BAYER MEDICAL CARE INC.

Fluid transfer set, general-purpose

• Primary Device ID: 10616258007837
• NIH Device Record Key: 9bf11aa5-146f-4b66-9ed3-c37845834347
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quick Fill Disposable Syringe Fill Tube
• Version Model Number: QFT 200
• Catalog Number: QFT 200
• 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
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• 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	00616258007830 [Primary]
GS1	10616258007837 [Package]; Contains: 00616258007830; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800823

FDA Product Code

• DXT: Injector And Syringe, Angiographic

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: 2016-09-24

On-Brand Devices [Quick Fill Disposable Syringe Fill Tube]

• 10616258007837: Individually Packaged Quick Fill Tubes (PKG,TUBE,QUICK FILL,QFT 200,RAD,MC,CH) (60729296)
• 10616258005802: Individually Packaged Quick Fill Tubes (QUICK FILL TUBE, MC) (60729288)
• 40616258022008: TUBE,QUICK FILL,MC,WLD (86660369)
• 40616258024477: TUBE,QUICK FILL, MC,CORE (87622959)