MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector SIT 96V

GUDID 00616258021119

SET,PKG,SIT96V,HEREDIA,RAD,MC,LA (86105500)

BAYER MEDICAL CARE INC.

Radiographic procedure tubing

• Primary Device ID: 00616258021119
• NIH Device Record Key: 2b4e16d2-4f64-4d51-980d-82f75452ecab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector
• Version Model Number: SIT 96V
• Catalog Number: SIT 96V
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258021119 [Primary]
GS1	40616258021117 [Package]; 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: 2019-03-04
• Device Publish Date: 2019-02-01

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

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• 10616258005529: Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a
• 40616258010005: Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a
• 40616258021834: ASSY,TUBE SET,SPECTRIS,96”,MC,WLD (86653516)
• 40616258021131: SET,PKG,SIT96V,HEREDIA,RAD,MC,JA2 (86105489)
• 40616258021124: SET,PKG,SIT96V,HEREDIA,RAD,MC,CH (86105497)
• 00616258021119: SET,PKG,SIT96V,HEREDIA,RAD,MC,LA (86105500)
• 40616258021100: SET,PKG,INTEG T/CV,SIT96V,HEREDIA,RAD,MC (86105438)