MEDRAD® PRES

Basic Information

• Brand Name: MEDRAD® PRES
• Primary DI: 00616258022635
• Version / Model: PRES50
• Catalog Number: PRES50
• Company Name: BAYER MEDICAL CARE INC.
• Labeler DUNS: 058716649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-21
• Public Version: 1
• Public Version Date: 2021-04-29
• Public Version Status: New
• Public Device Record Key: fe002289-882e-4a52-b556-a1c4adcf5cd8

Device Description

ASSY, TBG, PRES 50, MC (86990679)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40616258022633	GS1		50	In Commercial Distribution	9999-12-31
Primary	00616258022635	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K083723	000