MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube SJS-LP-60-T-J

GUDID 40616258021186

ASSY,T-CON 14",SJS-LP-60-T-J,FLEX,MC,JA2 (86310228)

BAYER MEDICAL CARE INC.

Radiographic procedure tubing

• Primary Device ID: 40616258021186
• NIH Device Record Key: 4e67166b-6bef-4e42-a201-36400c979645
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube
• Version Model Number: SJS-LP-60-T-J
• Catalog Number: SJS-LP-60-T-J
• 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: false
• 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	00616258021188 [Primary]
GS1	40616258021186 [Package]; Contains: 00616258021188; Package: [50 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: 2018-10-08
• Device Publish Date: 2018-09-06

On-Brand Devices [MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube]

• 40616258021186: ASSY,T-CON 14",SJS-LP-60-T-J,FLEX,MC,JA2 (86310228)
• 40616258021179: ASSY,FNL,T-CONN,6",SSS-LP-60-T,FLEX MC (86310201)
• 40616258021162: Stellant 60" low pressure connector tube with prime tube (ASSY,FNAL,LPCT,W/PTUBE,SSS-LP-60,FLEX,
• 40616258010937: Stellant 60"" low pressure connector tube with six-inch T-connector (ASSY,FINAL,T-CONN,6",SSS-LP
• 40616258010920: Stellant 60" low pressure connector tube with prime tube (ASSY,LPCT,W/PRIMETUBE,SSS-LP-60,RU,MC)
• 40616258009986: Stellant 60" low pressure connector tube with prime tube (ASSY,FNAL,LPCT,PRIMETUBE,SSS-LP-60-T-J
• 40616258009979: Stellant 60" low pressure connector tube with prime tube (ASSY,FNAL,LPCT,PRIMETUBE,SSS-LP-60,MC,
• 10616258007974: "Stellant 60"" low pressure connector tube with six-inch T-connector (ASSY,FINAL,T-CONNECTOR,6""
• 10616258007400: Stellant 60" low pressure connector tube with six-inch T-connector (ASSY,FINAL,T-CONN,6", SSS-LP
• 10616258007165: "Stellant 60"" low pressure connector tube with prime tube (ASSY,FNL,LPCT,W/PRIME,SSS-LP-60,MC,J
• 00616258007151: "Stellant 60"" low pressure connector tube with six-inch T-connector (ASSY,FINAL,T-CON,6"",SSS-L
• 10616258005277: Stellant 60" low pressure connector tube with prime tube (CT - 60" CONNECTOR TUBING, PT, SSS-LP-
• 10616258005260: Stellant 60" low pressure connector tube with six-inch T-connector (CT - 60" T-CONNECT TUBING,PT
• 40616258009962: ASSY,FINAL,T-CON,6",SSS-LP-60-T,MC,JA2 (85233033)
• 40616258021933: ASSY,TUBE SET,LPCT,TC,STLNT,MC,WLD2 (86645653)
• 40616258021926: ASSY,TUBE SET,LPCT,TC,STLNT,MC,WLD (86645610)
• 40616258021902: ASSY,TUBE SET,LPCT,STELLANT,MC,WLD (86645564)
• 40616258024811: ASSY,TUBE SET,LPCT,TC,STLNT,MC,CORE2 (87622770)
• 40616258024545: ASSY,TUBE SET,LPCT,TC,STLNT,MC,CORE (87622983)
• 40616258024538: ASSY,TUBE SET,LPCT,STELLANT,MC,CORE (87622975)