Disposable MRI Kit for 65/115 MR Injector System SSQK 65/115VS

GUDID 00616258007359

Spectris Solaris MR Kit (Includes 65 ML Qwik-Fit Syringe, 115 ML Qwik-Fit Syringe for Saline, 1 large spike, 1 small spike for contrast, 96" low pressure tubing with T-connector and Check Valve) (KIT,65/115ML,96"CT/CV,MRI, MC, LA) (60728575)

BAYER MEDICAL CARE INC.

Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe

• Primary Device ID: 00616258007359
• NIH Device Record Key: d2ec6ea2-7b79-4091-834d-767e489fe011
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable MRI Kit for 65/115 MR Injector System
• Version Model Number: SSQK 65/115VS
• Catalog Number: SSQK 65/115VS
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258007359 [Primary]
GS1	10616258007356 [Package]; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Disposable MRI Kit for 65/115 MR Injector System]

• 40616258009993: KIT,65/115ML,96"CT/CV,MRI, MC,JA2 (85233041)
• 00616258007786: Spectris Solaris MR Kit (Includes 65 ML Qwik-Fit Syringe, 115 ML Qwik-Fit Syringe for Saline, 1
• 00616258007359: Spectris Solaris MR Kit (Includes 65 ML Qwik-Fit Syringe, 115 ML Qwik-Fit Syringe for Saline, 1
• 10616258007141: "Spectris Solaris MR Kit (Includes 65 ML Qwik-Fit Syringe, 115 ML Qwik-Fit Syringe for Saline, 1
• 00616258005423: Spectris Solaris MR Kit (Includes 65 ML Qwik-Fit Syringe, 115 ML Qwik-Fit Syringe for Saline, 1
• 40616258021612: SOLARIS,KIT,SYR,MRI,65/115ML,MC,WLD2 (86595664)
• 40616258021605: KIT,65/115ML,96"CT/CV,MRI, MC,JA2 (85233041)SOLARIS,KIT,SYR,MRI,65/115ML,MC,WLD (86594218)
• 40616258024316: SOLARIS,KIT,SYR,MRI,65/115ML,MC,CORE (87622460)