Low Pressure Connector Tubing LPDCT 160

GUDID 40616258021971

ASSY,TBG,LPDCT,60”,COILED,MC,WLD (86660261)

BAYER MEDICAL CARE INC.

Radiographic procedure tubing

• Primary Device ID: 40616258021971
• NIH Device Record Key: 295b0e64-40aa-4b12-a10e-a2d341b55f26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Low Pressure Connector Tubing
• Version Model Number: LPDCT 160
• Catalog Number: LPDCT 160
• 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
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• 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	00616258021973 [Primary]
GS1	40616258021971 [Package]; Contains: 00616258021973; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831188

FDA Product Code

• DOY: Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.

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

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• 10616258007288: "Envision, Vistron, MCT - Coiled 60"" Low Pressure Connector Tube (SET, PKG, LPDCT 160, RAD, MC,
• 10616258005635: Envision, Vistron, MCT - Coiled 60" Low Pressure Connector Tube (SET, PKG, LPDCT 160, RAD, MC) (
• 40616258010128: Envision, Vistron, MCT - Coiled 60" Low Pressure Connector Tube (SET, PKG, LPDCT 160, RAD, MC,JA
• 40616258021988: ASSY,TBG,LPDCT,60”,COILED,MC,WLD2 (86661004)
• 40616258021971: ASSY,TBG,LPDCT,60”,COILED,MC,WLD (86660261)
• 40616258027133: ASSY,TUBE,SET,LPDCT 160,MICR,WLD,FINAL (890030204)
• 40616258024446: ASSY,TBG,LPDCT,60",COILED,MC,CORE (87622932)