MEDRAD® lntego PET Infusion System INT SYS 200

GUDID 00616258025834

SYSTEM,INTEGO,INT SYS 200,4ED,WS,U (88203682)

BAYER MEDICAL CARE INC.

General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered

• Primary Device ID: 00616258025834
• NIH Device Record Key: 227e9192-e737-47ba-a1d5-d11cd28f3dac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® lntego PET Infusion System
• Version Model Number: Intego
• Catalog Number: INT SYS 200
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258025834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100798

FDA Product Code

• FRN: Pump, Infusion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-15
• Device Publish Date: 2021-11-05

On-Brand Devices [MEDRAD® lntego PET Infusion System]

• 00616258020310: SYSTEM,INTEGO,INT SYS 200,RDMS,ROW2 (85746715)
• 00616258025834: SYSTEM,INTEGO,INT SYS 200,4ED,WS,U (88203682)