ICU Medical

Basic Information

• Brand Name: ICU Medical
• Primary DI: 00887709097346
• Version / Model: CL4139
• Catalog Number: CL4139
• Company Name: ICU MEDICAL, INC.
• Labeler DUNS: 118380146
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-23
• Public Version: 1
• Public Version Date: 2023-08-31
• Public Version Status: New
• Public Device Record Key: 340fbc12-5159-4082-ad4d-c53d27c24ea6

Device Description

60" (152 cm) Appx 1.0 ml, Smallbore Ext Set w/ChemoLock™ Port, ChemoLock™ w/Red Cap, 0.2 Micron Filter, Clamp

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
ONB	Closed antineoplastic and hazardous drug reconstitution and transfer system	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	10887709097343	GS1	BOX	50	In Commercial Distribution
Primary	00887709097346	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131549	000