CLOTtrac™

Basic Information

• Brand Name: CLOTtrac™
• Primary DI: 00763000558185
• Version / Model: 550-01
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-22
• Public Version: 1
• Public Version Date: 2026-03-02
• Public Version Status: New
• Public Device Record Key: e6dbba13-4051-4618-8dd0-298e40884ef9

Device Description

CONTROL 550-01 CLOTTRAC CWB

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JPA	SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30590	Multiple coagulation factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20763000558189	GS1	PK	15	In Commercial Distribution
Primary	00763000558185	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K894359	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 10 Degrees Celsius