MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve SSIT 96VLD

GUDID 40616258021865

ASSY,TUBE SET,SOLARIS,96”,MC,WLD2 (86645343)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 40616258021865
• NIH Device Record Key: 92ff5201-d366-4334-961f-1bd76250c06a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve
• Version Model Number: SSIT 96VLD
• Catalog Number: SSIT 96VLD
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258021867 [Primary]
GS1	40616258021865 [Package]; Contains: 00616258021867; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042784

FDA Product Code

• DXT: Injector And Syringe, Angiographic

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: 2019-11-04
• Device Publish Date: 2019-10-25

On-Brand Devices [MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve]

• 10616258007820: 96" low pressure connector tube with T-connector and check valve for Spectris Solaris (SET,PKG,
• 10616258007394: 96" low pressure connector tube with T-connector and check valve for Spectris Solaris (SET,PKG,I
• 10616258007301: 96" low pressure connector tube with T-connector and check valve for Spectris Solaris (SET,PKG,I
• 10616258005451: 96" low pressure connector tube with T-connector and check valve for Spectris Solaris (MR - 96"
• 40616258010012: 96" low pressure connector tube with T-connector and check valve for Spectris Solaris (SET,PKG,I
• 40616258021865: ASSY,TUBE SET,SOLARIS,96”,MC,WLD2 (86645343)
• 40616258021858: ASSY,TUBE SET,SOLARIS,96”,MC,WLD (86645300)