Disposable MRI Kit with Check Valve SQK 65VS

GUDID 00616258007779

Spectris MR Injector Kit (Includes: (2) 65 ML Front Load syringes, 96" low pressure tubing with an integrated check valve, 1 large spike for loading saline, 1 small spike (KIT,SYR/SPIKE/T,65mL FLS,MRI,MC,CH) (60728559)

BAYER MEDICAL CARE INC.

Angiographic syringe Angiographic syringe

• Primary Device ID: 00616258007779
• NIH Device Record Key: dd00fe6b-fbfe-4d90-a475-abde97efebea
• 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
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258007779 [Primary]
GS1	10616258007776 [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: 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 with Check Valve]

• 00616258007779: Spectris MR Injector Kit (Includes: (2) 65 ML Front Load syringes, 96" low pressure tubing with
• 00616258007342: Spectris MR Injector Kit (Includes: (2) 65 ML Front Load syringes, 96" low pressure tubing with
• 10616258007011: Spectris MR KIT,SYR/SPIKE/T,65ML FLS,MRI,BURRON and FFA 50 (KIT,SYR/SPIKE/T,65ML FLS,MRI,BUR, MC
• 10616258005475: Spectris MR KIT,SYR/SPIKE/T,65ML FLS,MRI,BURRON and FFA 50 (MR - SPECTRIS SYRINGE KIT, 2-65ML, F
• 00616258005447: Spectris MR Injector Kit (Includes: (2) 65 ML Front Load syringes, 96" low pressure tubing with
• 40616258010036: Spectris MR KIT,SYR/SPIKE/T,65ML FLS,MRI,BURRON and FFA 50 (KIT,SYR/SPIKE/T,65ML FLS,MRI,BUR, MC
• 40616258021582: SPECTRIS,KIT,SYR,MRI,65ML,CHK,MC,WLD (86595656)
• 40616258021568: SPECTRIS,KIT,SYR,MRI,65ML,MC,WLD (86594188)
• 40616258024309: SPECTRIS,KIT,SYR,MRI,65ML,CHK,MC,CORE (87622444)