ULTRASITE®

Basic Information

• Brand Name: ULTRASITE®
• Primary DI: 04046964297458
• Version / Model: 470026
• Catalog Number: 470026
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2017-01-05
• Public Version: 3
• Public Version Date: 2018-05-02
• Public Version Status: Update
• Public Device Record Key: fba5c56f-f268-40cd-b72b-9f22d760d3b8
• Distribution End Date: 2018-04-28

Device Description

US1500XHP OUTLOOK PUMP SET W/ ULTRASITE

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
35833	Electric infusion pump administration set, single-use	A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964297458	GS1
Unit of Use	04046964297441	GS1

Customer Contacts

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