ICU Medical

Basic Information

• Brand Name: ICU Medical
• Primary DI: 00887709042087
• Version / Model: SMV3V3
• Catalog Number: SMV3V3
• Company Name: ICU MEDICAL, INC.
• Labeler DUNS: 118380146
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-24
• Public Version: 1
• Public Version Date: 2021-09-01
• Public Version Status: New
• Public Device Record Key: 04ab21e4-d2a8-4f0f-88c0-26533b8450e5

Device Description

3-Gang 1o2™ Manifold w/Back Check Valve, Rotating Luer

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
34099	In-line backflow valve, single-use	A general-purpose device used in medical or laboratory tubing to prevent the backflow of gases or liquids. It will typically have a small ball or a leaf valve that instantly closes should a retrograde pressure (backflow) occur. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10887709042084	GS1	CS	50	In Commercial Distribution
Primary	00887709042087	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K974589	000