MEDRAD® Stellant FLEX Syringe Kit FLEXS-200-QFT

GUDID 40616258022879

STLNT,KIT,SYR,CT,S,QFT,FLS3,200ML,WLD (87078809)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 40616258022879
• NIH Device Record Key: decad912-ee88-47e7-9833-6ae73fb28562
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Stellant FLEX Syringe Kit
• Version Model Number: FLEXS-200-QFT
• Catalog Number: FLEXS-200-QFT
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258022871 [Primary]
GS1	40616258022879 [Package]; Contains: 00616258022871; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173773

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: 2020-01-01
• Device Publish Date: 2019-12-24

On-Brand Devices [MEDRAD® Stellant FLEX Syringe Kit ]

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• 70616258010648: Stellant Single 200mL Syringe Kit with LPDCT with T-Connector and 1 sterile spike (STLNT,KIT,SYR
• 70616258010624: Stellant Dual 200mL Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (STLNT,KIT,SYR,
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• 40616258022879: STLNT,KIT,SYR,CT,S,QFT,FLS3,200ML,WLD (87078809)
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• 40616258022824: STLNT,KIT,SYR,CT,S,SPK,FLS3,200ML,WLD (87078744)
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• 70616258010631: STLNT,KIT,SYR,CT,D,QFT,FLS3,200ML,RW (85074199)