MEDRAD® Intego Sterile Disposables INT CSS

GUDID 00616258020242

INTEGO,ASSY,TUBE SET,SAS,MIM,FINAL (85890174)

BAYER MEDICAL CARE INC.

Electric infusion pump administration set, reusable

• Primary Device ID: 00616258020242
• NIH Device Record Key: 399b946d-4766-4152-af93-aef794d76c9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Intego Sterile Disposables
• Version Model Number: INT CSS
• Catalog Number: INT CSS
• 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: 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	00616258020242 [Primary]
GS1	40616258020240 [Package]; Package: [20 Units]; In Commercial Distribution
GS1	70616258020241 [Package]; Package: [400 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080297

FDA Product Code

• FRN: Pump, Infusion

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: 2018-11-05
• Device Publish Date: 2018-10-05

On-Brand Devices [MEDRAD® Intego Sterile Disposables]

• 00616258020242: INTEGO,ASSY,TUBE SET,SAS,MIM,FINAL (85890174)
• 10616258005291: Intego Source Admin Set (SAS) (Intego - Source Administration Set) (60766884)
• 40616258021476: ASSY,TBG,SAS,SPIKE,T-CONN,MC,WLD (86566621)
• 40616258024835: ASSY,TBG,SAS,SPIKE,T-CONN,MC,CORE (87640477)