MEDRAD® Stellant FLEX Syringe Kit FLEXD-200-SCS

GUDID 40616258022862

STLNT,KIT,SYR,CT,D,SCS,FLS3,200ML,WLD (87078787)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 40616258022862
• NIH Device Record Key: 77fd05f4-5d71-4d2d-8691-9bfa622b1748
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Stellant FLEX Syringe Kit
• Version Model Number: FLEXD-200-SCS
• Catalog Number: FLEXD-200-SCS
• 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	00616258022864 [Primary]
GS1	40616258022862 [Package]; Contains: 00616258022864; Package: [20 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]

• 70616258010679: Stellant Single 150mL Syringe Kit with LPDCT with T-Connector and 1 sterile spike (STLNT,KIT,SYR
• 70616258010655: Stellant Dual 150mL Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (STLNT,KIT,SYR,
• 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,
• 40616258022909: STLNT,KIT,SYR,CT,D,SPK,FLS3,150ML,WLD (87078833)
• 40616258022893: STLNT,KIT,SYR,CT,S,QFT,FLS3,150ML,WLD (87078825)
• 40616258022886: STLNT,KIT,SYR,CT,D,SCS,FLS3,150ML,WLD (87078817)
• 40616258022879: STLNT,KIT,SYR,CT,S,QFT,FLS3,200ML,WLD (87078809)
• 40616258022862: STLNT,KIT,SYR,CT,D,SCS,FLS3,200ML,WLD (87078787)
• 40616258022855: STLNT,KIT,SYR,CT,D,QFT,FLS3,200ML,WLD (87078779)
• 40616258022848: STLNT,KIT,SYR,CT,S,SPK,FLS3,150ML,WLD (87078760)
• 40616258022831: STLNT,KIT,SYR,CT,D,SPK,FLS3,150ML,WLD (87078752)
• 40616258022824: STLNT,KIT,SYR,CT,S,SPK,FLS3,200ML,WLD (87078744)
• 40616258022817: STLNT,KIT,SYR,CT,D,SPK,FLS3,200ML,WLD (87078728)
• 70616258021033: STLNT,KIT,SYR,CT,S,QFT,FLS3,150ML,RW (86016346)
• 70616258021026: STLNT,KIT,SYR,CT,S,QFT,FLS3,200ML,RW (86016338)
• 70616258021019: STLNT,KIT,SYR,CT,D,SCS,FLS3,150ML,RW (86016028)
• 70616258021002: STLNT,KIT,SYR,CT,D,SCS,FLS3,200ML,RW (86015889)
• 70616258010631: STLNT,KIT,SYR,CT,D,QFT,FLS3,200ML,RW (85074199)