CT TRI-PAK Sterile Disposable Syringe CTP-200-FLS

GUDID 00616258005430

Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (CT - 200ML ENV/VIST SYRINGE KIT W/QFT) (60728656)

BAYER MEDICAL CARE INC.

Angiographic syringe Angiographic syringe

• Primary Device ID: 00616258005430
• NIH Device Record Key: e087900c-aa39-4724-b8c6-477fffb19ea1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT TRI-PAK Sterile Disposable Syringe
• Version Model Number: CTP-200-FLS
• Catalog Number: CTP-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: 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: true
• Labeled No Natural Rubber Latex: false
• 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	00616258005430 [Primary]
GS1	10616258005437 [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

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