Imaging System Interface - ISI2 Module ISI2

GUDID 00616258022512

ASSY, Module, ISI2 (86882302)

Bayer Medical Care Inc.

CT contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258022512
• NIH Device Record Key: 3370ca6d-f851-4576-ab28-e6833b254157
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imaging System Interface - ISI2 Module
• Version Model Number: ISI2
• Catalog Number: ISI2
• Company DUNS: 049673973
• 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: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com
• Phone: 1-800-866-7231
• Email: ricustomercomplaints@bayer.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258022512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182273

FDA Product Code

• DXT: Injector And Syringe, Angiographic

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: 2024-05-14
• Device Publish Date: 2024-05-06

On-Brand Devices [Imaging System Interface - ISI2 Module]

• 00616258022512: ASSY, Module, ISI2 (86882302)
• 00616258027340: ASSY,MODULE,ISI2,CORE (89302900)