200mL Sterile Disposable Qwik-Fit Syringe & QFT 200-FLS-Q

GUDID 00616258005492

Envision, Vistron, MCT- 200 ml syringe with quick fill tube (CT - 200ML ENV/VIST SYRINGE KIT W/QFT) (60728648)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 00616258005492
• NIH Device Record Key: 3efd7885-415d-4e68-b56f-168addc14819
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 200mL Sterile Disposable Qwik-Fit Syringe & QFT
• Version Model Number: 200-FLS-Q
• Catalog Number: 200-FLS-Q
• 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	00616258005492 [Primary]
GS1	10616258005499 [Package]; 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 & QFT]

• 10616258007523: Envision, Vistron, MCT- 200 ml syringe with quick fill tube (CT - 200ML ENV/VIST SYRINGE KIT W/Q
• 10616258007240: "Envision, Vistron, MCT- 200 ml syringe with quick fill tube (ASSY,PKG,SYR,200ML W/QFT,ODYSSY,MC
• 00616258005492: Envision, Vistron, MCT- 200 ml syringe with quick fill tube (CT - 200ML ENV/VIST SYRINGE KIT W/Q
• 00616258010090: Envision, Vistron, MCT- 200 ml syringe with quick fill tube (ASSY,PKG,SYR,200ML W/QFT,ODYSSY,MC,