MEDRAD® Intego PET Infusion System INT SYS 200

GUDID 00616258021379

SYSTEM,INTEGO,INT SYS 200,4ED,MC (86443090)

BAYER MEDICAL CARE INC.

Bedside infusion pump, single-channel

• Primary Device ID: 00616258021379
• NIH Device Record Key: 4f0f8724-2443-4fa2-89ec-c390e82723e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Intego 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
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258021379 [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: 2023-05-11
• Device Publish Date: 2023-05-03

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

• 00616258021324: SYSTEM, INTEGO, INT SYS 200, RDMS, UPGRADED (86184486)
• 00616258009650: "SYSTEM,INTEGO,INT SYS 200,MC (60726777)"
• 00616258008738: "VIAL SHIELD,10H,BLACK,SNAP RING,MC (84180211)"
• 00616258008721: "VIAL SHIELD,20H,GOLD,SNAP RING,MC (84194174)"
• 00616258008714: "VIAL SHIELD,15R,BROWN,SNAP RING,MC (84194085)"
• 00616258008707: "VIAL SHIELD,10R,GREEN,SNAP RING,MC (84193992)"
• 00616258008691: "VIAL SHIELD,20R,BLUE,SNAP RING,MC (84135054)"
• 00616258008684: INTEGO - VIAL SHIELD, MC (85278150)
• 00616258008677: "VIAL SHIELD,10 ML,VIOLET,SNAP RING,MC (84179876)"
• 00616258008653: "SYSTEM, INTEGO, INT SYS 200, RDMS (84731544)"
• 00616258025360: SYSTEM,INTEGO,INT SYS 200,4ED,WS (87978443)
• 00616258021379: SYSTEM,INTEGO,INT SYS 200,4ED,MC (86443090)