CMExpress® Microbore Set with Needleless Y-Site

Basic Information

• Brand Name: CMExpress® Microbore Set with Needleless Y-Site
• Primary DI: 00818666020344
• Version / Model: A120-161CYF
• Company Name: CME AMERICA LLC
• Labeler DUNS: 002125419
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-21
• Public Version: 4
• Public Version Date: 2020-07-09
• Public Version Status: Update
• Public Device Record Key: df98fb8a-e1af-4b1a-a755-b4447270ab7a
• Distribution End Date: 2020-07-08

Device Description

105 in. (267 cm) CMExpress® Microbore Set w/ Needleless Y-Site For Use with the CMExpress® Infusion Pump

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: 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
Package	10818666020341	GS1	Case	50	Not in Commercial Distribution	2020-07-08
Primary	00818666020344	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042696	000