Disposable MRI Kit with Check Valve SQK 65VS

GUDID 40616258021582

SPECTRIS,KIT,SYR,MRI,65ML,CHK,MC,WLD (86595656)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 40616258021582
• NIH Device Record Key: d8be7470-95b0-4910-97f1-5b08ec394c79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable MRI Kit with Check Valve
• Version Model Number: SQK 65VS
• Catalog Number: SQK 65VS
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258021584 [Primary]
GS1	40616258021582 [Package]; Contains: 00616258021584; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980417

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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

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