MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube ART 700 SYR

GUDID 40616258021629

ARTERION,KIT,SYR,ANGIO,150ML,MC,WLD (86617439)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 40616258021629
• NIH Device Record Key: a5149e44-715d-4686-bda3-d9daa013747e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube
• Version Model Number: ART 700 SYR
• Catalog Number: ART 700 SYR
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258021621 [Primary]
GS1	40616258021629 [Package]; Contains: 00616258021621; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112086

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: 2019-11-04
• Device Publish Date: 2019-10-25

On-Brand Devices [MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube]

• 00616258010069: SYRINGE KIT,PACKAGED,,150FT,MK 7 (SYR,KIT,PACKAGED,MEDRAD,150FT,MK7,MC,JA2) (85232924)
• 10616258007844: SYRINGE KIT,PACKAGED,,150FT,MK 7 (SYRINGE KIT,PACKAGED,150FT,M7,MC,CH) (60729393)
• 10616258007080: "SYRINGE KIT,PACKAGED,,150FT,MK 7 (SYR,KIT,PACKAGED,MEDRAD,150FT,MK7,MC,JA) (84194972)"
• 10616258005543: SYRINGE KIT,PACKAGED,,150FT,MK 7 (ANGIO-ARTERION, 150ML SYR KIT W/QFT,MC) (60729385)
• 40616258021636: ARTERION,KIT,SYR,ANGIO,150ML,MC,WLD2 (86617447)
• 40616258021629: ARTERION,KIT,SYR,ANGIO,150ML,MC,WLD (86617439)
• 40616258024781: ARTERION,KIT,SYR,ANGIO,150ML,MC,CORE2 (87622754)
• 40616258024354: ARTERION,KIT,SYR,ANGIO,150ML,MC,CORE (87622509)