CT TRI-PAK Sterile Disposable Syringe CTP-125-FLS

GUDID 00616258005485

Tri-Pak (Includes:125 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (CT - 125ML ENV/VIST SYR KIT W/QFT,LPCT) (60728613)

BAYER MEDICAL CARE INC.

Angiographic syringe Angiographic syringe

• Primary Device ID: 00616258005485
• NIH Device Record Key: 07272ef8-3b26-4f9e-8f6f-72071e5a9b85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT TRI-PAK Sterile Disposable Syringe
• Version Model Number: CTP-125-FLS
• Catalog Number: CTP-125-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: 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	00616258005485 [Primary]
GS1	10616258005482 [Package]; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934086

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 [CT TRI-PAK Sterile Disposable Syringe]

• 00616258007793: Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (AS
• 00616258007366: Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (AS
• 10616258007264: "Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60"" Low Pressure Connector Tube) (
• 00616258005485: Tri-Pak (Includes:125 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (CT
• 00616258005430: Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (CT
• 40616258010104: ASSY,PKG,SYR,TRI-PAK,200ML,ODY,MC,JA2 (85231421)
• 40616258021964: MULTI,KIT,SYR,CT,200ML,MC,WLD (86660237)
• 40616258024385: MULTI,KIT,SYR,CT,200ML,MC,CORE (87622576)