200mL Sterile Disposable Qwik-Fit Syringe 200-FLS

GUDID 10616258007233

"Envision, Vistron, MCT- 200 ml syringe (ASSY,PKG,SYRINGE, 200ML, ODYSSEY,MC,JA) (84197076)"

BAYER MEDICAL CARE INC.

Angiographic syringe Angiographic syringe

• Primary Device ID: 10616258007233
• NIH Device Record Key: 7291779a-80f5-4801-966f-c76ab9979c13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 200mL Sterile Disposable Qwik-Fit Syringe
• Version Model Number: 200-FLS
• Catalog Number: 200-FLS
• 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
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258007236 [Primary]
GS1	10616258007233 [Package]; Contains: 00616258007236; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924116

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 [200mL Sterile Disposable Qwik-Fit Syringe]

• 10616258007233: "Envision, Vistron, MCT- 200 ml syringe (ASSY,PKG,SYRINGE, 200ML, ODYSSEY,MC,JA) (84197076)"
• 00616258005508: Envision, Vistron, MCT- 200 ml syringe (CT - 200ML ENV/VIST SYRINGE KIT) (60728621)
• 40616258010081: Envision, Vistron, MCT- 200 ml syringe (ASSY,PKG,SYRINGE, 200ML, ODYSSEY,MC,JA2) (85232851)