ICU Medical

Basic Information

• Brand Name: ICU Medical
• Primary DI: 00840619046354
• Version / Model: 011-0E519-01
• Catalog Number: 011-0E519-01
• Company Name: ICU MEDICAL, INC.
• Labeler DUNS: 118380146
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-11
• Public Version: 1
• Public Version Date: 2024-01-19
• Public Version Status: New
• Public Device Record Key: e5de94b5-4df2-419f-958e-f4f544cfc73e

Device Description

Accudynamic® Damping Device

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
DRS	Transducer, blood-pressure, extravascular	Cardiovascular	870.2850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32172	Intravenous line stopcock	A sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10840619046351	GS1	BOX	30	In Commercial Distribution
Primary	00840619046354	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K801048	000